[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"emphysema-or-copd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:emphysema-or-copd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,81,116,143,164,193,221,258,281,312,336,365,386],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100642289","improve-muscle-weakness-in-patient-with-copd-100642289",false,"NCT07649850","Improve Muscle Weakness in Patient With COPD","Aerobic Exercise Combined With Blood Flow Restriction Improves Muscle Strength and Functional Capacity In Patients With Emphysematous COPD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with emphysematous chronic obstructive pulmonary disease (COPD).\n* Clinically stable COPD patients with no acute exacerbation within the previous 4-6 weeks.\n* Mild to moderate disease severity according to GOLD criteria.\n* Ability to participate safely in aerobic exercise training.\n* Medically stable and cleared by a physician for pulmonary rehabilitation.\n* Ability to understand and follow study instructions.\n\nExclusion Criteria:\n\n* Acute COPD exacerbation or respiratory infection during the study period.\n* Severe cardiovascular diseases (e.g., unstable angina, uncontrolled hypertension, recent myocardial infarction).\n* Peripheral vascular disease or contraindications to blood flow restriction (BFR) training.\n* Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise performance.\n* Cognitive impairment affecting cooperation or informed consent.\n* Participation in another structured rehabilitation program during the study period.\n* Severe hypoxemia requiring continuous oxygen therapy during exercise.\n* History of deep vein thrombosis or clotting disorders.","ALL","50 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial investigated the effects of combining aerobic exercise with blood flow restriction (BFR) training in patients with emphysematous chronic obstructive pulmonary disease (COPD). The study aimed to determine whether adding BFR to aerobic exercise could enhance muscle strength and functional capacity compared with conventional training alone. The findings demonstrated that aerobic exercise combined with BFR significantly improved lower-limb muscle strength, exercise tolerance, and functional performance in patients with emphysematous COPD. These results suggest that BFR-assisted aerobic training may serve as an effective and safe rehabilitation strategy to improve physical function and quality of life in this population.",[27],"Emphysema or COPD",[29,30,31],"emphysematous COPD","lood flow restriction (BFR)","aerobic exercise","NOT_YET_RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":21},"2026-06-10",{"date":40,"type":21},"2026-08-30",{"name":42,"class":43},"Al-Zaytoonah University of Jordan","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100602109","a-multi-center-study-testing-a-new-implant-for-adults-with-severe-emphysema-100602109","NCT07119229","A Multi Center Study Testing a New Implant for Adults With Severe Emphysema","A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema","IAB-2","Inclusion Criteria:\n\n1. Signed Informed Consent.\n2. Diagnosis of COPD\u002Femphysema.\n3. At least 22-years of age.\n4. 18 ≤ BMI ≤ 32.\n5. 6-minute walk Distance between 100-meters and 400-meters at baseline exam.\n6. Stable disease with less than 10-mg prednisone (or equivalent) daily\n7. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).\n8. FEV1 between 15% and 50% of predicted value at baseline exam.\n9. FEV1\u002FFVC \\\u003C70%.\n10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \\\u003C-950 HU, as determined by CT core lab.\n11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (\\\u003C -950HU) as determined by CT core lab.\n12. RV \\> 175% of predicted value.\n13. mMRC score ≥ 2.\n\nExclusion Criteria:\n\n* 1\\. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..\n\n  2\\. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.\n\n  5\\. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.\n\n  6\\. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.\n\n  7\\. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable \u002F uncontrolled congestive heart failure within 6-months of screening.\n\n  9\\. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).\n\n  10\\. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.\n\n  12\\. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3-months prior to screening visit). Note: the echocardiogram is not a required screening procedure.\n\n  13\\. Suspected malignant pulmonary nodule or other lung cancer. 14. HRCT collected per CT scanning protocol within the last 6-months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:\n  1. Large bullae encompassing greater than 30% of either lung\n  2. Insufficient landmarks to evaluate the CT study using the software as it is intended\n  3. All lobes are less than 25% parenchyma diseased (\\\u003C -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.\n\n     16\\. TLC \\\u003C 100% predicted at screening. 17. DLCO \\\u003C 15% or \\> 50% of predicted value at screening. 18. PaCO2 \\> 50 mm Hg at screening. 19. PaO2 \\\u003C 45 mm Hg in room air at screening. 20. Plasma cotinine level \\> 13.7 ng\u002Fml or carboxyhemoglobin (arterial or ear lobe capillary) \\>2.5% at screening.\n\n     21\\. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.\n\n     23\\. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.","22 Years",{"count":20,"type":21},[24],"A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD\u002Femphysema works, and how safe it is.",[27,57,58],"Emphysema","COPD",[60,61,62,63,64,65,66,67,68],"IAB","Stent","Emphysema treatment","emphysema study","COPD treatment","COPD study","EBV alternative","Lung volume reduction","Lung hyperinflation treatment","RECRUITING","2026-06-02",{"date":72,"type":36},"2026-06-03",{"date":74,"type":36},"2026-03-25",{"date":76,"type":21},"2027-11",{"name":78,"class":79},"Pulmair Medical, Inc.","INDUSTRY",3,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100521365","ultrasound-and-respiratory-physiological-signals-in-lung-diseases-100521365","NCT06068647","Ultrasound and Respiratory Physiological Signals in Lung Diseases","Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases","SAURON","Inclusion Criteria:\n\n* inpatients admitted to the hospital due to diffuse interstitial lung diseases during exacerbation OR infectious interstitial pneumonia not caused by SARS-CoV-2 OR acute exacerbation of chronic obstructive pulmonary disease.\n* Outpatients with pulmonary paraseptal and\u002For panlobular emphysema and\u002For chronic obstructive pulmonary disease during stable phase.\n* Patients able to give written informed consent.\n\nExclusion Criteria:\n\n* history of skin irritation, redness, itching or allergic cutaneous symptoms.\n* Allergic reactions to adhesives or hydrogels.\n* Family history of adhesive skin allergies.\n* Presence of severe skin conditions such as wounds, burns or on any damaged skin.\n* Presence of strong magnetic fields in the study setting.\n* Presence of electromagnetic disturbances or significant ionizing radiation sources which might lead to signal artifacts.\n* Use of external cardiac defibrillators.\n* Use of diaphragmatic pacers.\n* Use of extra cardiac stimulators.\n* Pregnancy.\n* Pediatric population.","18 Years",{"count":91,"type":21},25,[24],"The use of lung ultrasound is instrumental in the evaluation of many chest pathologies and its ability to detect pleuro-pulmonary pathology is widely accepted.\n\nHowever, the use of ultrasound to explore the state of the peripheral lung parenchyma, when the organ is still aerated, is a relatively new application.\n\nHorizontal and vertical artifacts are separate and distinct artifacts that can be seen during ultrasound examination of the lungs. While the practical role of lung ultrasound artifacts is accepted to detect and monitor many conditions, further research is needed for the physical interpretation of ultrasound artifacts. These artifacts are diagnostic signs, but we don't fully understand their origin.\n\nThe artifactual information deriving from the surface acoustic interaction, beyond the pleural line, in the ultrasound images of the normally aerated and non-deflated lung, represents the final result of complex interactions of acoustic waves with a specific three-dimensional structure of the biological tissue. Thus, the umbrella term \"vertical artifacts\" oversimplifies many physical phenomena associated with a pathological pleural plane. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma.\n\nTherefore, the need emerges to explore the physical phenomena underlying the artifactual ultrasound information deriving from the surface acoustic interaction of ultrasound with the pleuro-pulmonary structures.",[95,96,97,98,27,99,100,101],"Interstitial Lung Disease","Interstitial Lung Diseases","Interstitial Pneumonia","Chronic Obstructive Pulmonary Disease","Ultrasonography","Ultrasound Imaging","Ultrasound",[101,100,99,57,103,104,105],"Chronic obstructive pulmonary disease","Interstitial pneumonia","Interstitial lung disease","2026-05-19",{"date":108,"type":36},"2026-05-20",{"date":110,"type":36},"2023-03-22",{"date":112,"type":21},"2026-09-30",{"name":114,"class":43},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":115},"100459058","inter-lobar-fissure-completion-in-patients-with-failed-bronchoscopic-lung-volume-reduction-100459058","NCT05257681","Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction","Inter-lobar Fissure Completion as a Salvage Treatment in Patients With Failed Bronchoscopic Lung Volume Reduction","SAVED-1","Inclusion Criteria:\n\n* Age 40 to 75 years.\n* Stable with less than 10mg prednisone (or equivalent) daily.\n* Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.\n* Current pneumococcus vaccination.\n* Current influenza vaccination.\n* Target lung volume reduction \\\u003C350ml after bronchoscopic lung volume reduction (BLVR).\n* Persistent dyspnea defined as an mMRC score greater or equal to 2 after bronchoscopic lung volume reduction (BLVR).\n* Endobronchial valves (EBV) are still in place.\n* Willing and able to complete protocol required study follow-up assessments and procedures.\n\nExclusion Criteria:\n\n* Clinically significant (greater than 4 tablespoons per day) mucus production.\n* Myocardial infarction within 6 months of screening.\n* Decompensated heart failure.\n* Three or more pneumonia episodes in last year.\n* Three or more COPD exacerbation episodes in the last year.\n* Prior lung transplant, LVRS, bullectomy, or lobectomy.\n* Clinically significant bronchiectasis.\n* Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.\n* Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Resting bradycardia (\\\u003C50 bpm), Complex ventricular arrhythmia, sustained SVT.\n* PaCO2 greater than 50mmHg on room air at screening.\n* PaO2 less than 45mmHg on room air at screening.","40 Years","75 Years",{"count":127,"type":21},20,[24],"The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema\u002FCOPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema\u002FCOPD.",[27],[58,132,98,57,133],"Chronic Obstructive Lung Disease","Video-assisted thoracic surgery","2026-04-07",{"date":136,"type":36},"2026-04-13",{"date":138,"type":36},"2022-05-24",{"date":140,"type":21},"2026-05-24",{"name":142,"class":43},"Beth Israel Deaconess Medical Center",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":115},"100423993","combined-zephyr-valve-system-with-inter-lobar-fissure-completion-for-lung-volume-reduction-in-emphysema-100423993","NCT04801108","Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema","Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema: A Pilot Randomized Controlled Trial","COMPLETE-1","Inclusion Criteria:\n\n* Age 40 to 75 years.\n* Stable with less than 10mg prednisone (or equivalent) daily.\n* Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.\n* Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.\n* Current pneumococcus vaccination.\n* Current influenza vaccination.\n* Willing and able to complete protocol required study follow-up assessments and procedures.\n\nExclusion Criteria:\n\n* \\> 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.\n* Clinically significant (greater than 4 tablespoons per day) mucus production.\n* Myocardial infarction within 6 months of screening.\n* Uncontrolled congestive heart failure.\n* Three or more pneumonia episodes in last year.\n* Three or more COPD exacerbation episodes in the last year.\n* Prior lung transplant, LVRS, bullectomy, or lobectomy.\n* Clinically significant bronchiectasis.\n* Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.\n* Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).\n* Resting bradycardia (\\\u003C50 beats\u002Fmin), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.\n* Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.\n* TLC less than 100% predicted (determined by body plethysmography at screening).\n* RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).\n* DLCO less than 20% of the predicted value at screening.\n* Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening.\n* PaCO2 greater than 50mmHg on room air at screening.\n* PaO2 less than 45mmHg on room air at screening",{"count":127,"type":21},[24],"The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing \"standard-of-care\") in select patients with severe COPD\u002Femphysema and with evidence for \\\u003C95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling.\n\nThe study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD\u002Femphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F\u002FU period, they will be eligible for EBV if they choose.",[27],[58,156,57,133,157],"Endobronchial valves","Robotic thoracic surgery",{"date":136,"type":36},{"date":160,"type":36},"2021-08-01",{"date":162,"type":21},"2026-08-01",{"name":142,"class":43},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100518790","an-evaluation-of-the-aeriseal-system-for-converting-collateral-ventilation-status-in-patients-with-severe-emphysema-100518790","NCT06035120","An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema","An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema: The CONVERT II Trial","CONVERT_II","Inclusion Criteria:\n\n1. Subject is willing and able to provide informed consent and to participate in the study.\n2. Subject is aged ≥ 40 and ≤ 80 years at the time of the ICF signature date.\n3. Subject has completed a documented pulmonary rehabilitation (in clinic or home-based) program within 12 months prior to Baseline.\n4. Subject has stopped smoking for at least 8 weeks prior to the ICF signature date as confirmed by carboxyhemoglobin or cotinine levels.\n5. Subject has a recent HRCT meeting the scan parameter requirements and performed within 3 months of the ICF signature date with the following findings at -910 Hounsfield Units:\n\n   1. At least one (1) lobe with segmental emphysema destruction score ≥ 50%.\n   2. Subject has heterogenous emphysema, defined as difference in emphysema destruction score of ≥ 15 between the density scores of the target lobe and the ipsilateral non-target lobe(s) per QCT report with % voxel density of \\\u003C -910 HU. For non-target lobes that include the RML, calculate the combination of non-target lobes as a single density score using volume-weighted percent.\n   3. LUL, LLL, RUL, RLL, or RUL+RML are targets for valve intervention.\n   4. Subject has a gap in the interlobar fissure that corresponds to one or more segments and the fissure(s) contacting the target lobe is ≥ 80% complete per QCT report.\n   5. Subject has 98% of the fissure gap confined to a maximum of 3 segments within the target lobe per Fissure Targeting Report (FTR).\n6. Subject has 6MWD ≥ 150 m and ≤ 450 m.\n7. Subject has clinically significant dyspnea with an mMRC score of ≥ 2.\n8. Subject has post-bronchodilation FEV1 ≥ 15% predicted and ≤ 45% predicted.\n9. Subject has an FEV1\u002FFVC ratio of \\\u003C 0.7.\n10. Subject has post-bronchodilation TLC, measured by body plethysmography, ≥ 100% predicted.\n11. Subject has post-bronchodilation RV ≥ 175% predicted, measured by body plethysmography.\n12. Subject has post-bronchodilation DLCO ≥ 20% predicted.\n13. Subject has received preventative vaccinations against potential respiratory infections, including COVID-19, consistent with local recommendation or policy.\n14. Subject is on optimal medical management for more than one month prior to the ICF signature date.\n15. Subject has collateral ventilation (CV+) as confirmed per the Chartis assessment prior to the AeriSeal Index Procedure.\n\nExclusion Criteria:\n\n1. Subject has prior lung volume reduction surgery, lobectomy or pneumonectomy, lung transplantation, airway stent placement, pleurodesis, or BLVR of any type, except BLVR using Zephyr Valve with \\\u003C 50% TLVR at 6 months, followed by valve removal \\> 6 months prior to ICF signature date.\n2. Subject has visible radiological abnormality on HRCT scan such as pulmonary nodule greater than 0.8 cm in diameter (does not apply, if present for 2 years or more without increase in size or if deemed benign by biopsy) or active pulmonary infection (e.g., unexplained parenchymal infiltrate, significant interstitial lung disease or significant pleural disease).\n3. Post-COVID-19 pathology on CT, including ground glass opacities with or without consolidation, adjacent pleura thickening, interlobular septal thickening, or air bronchograms.\n4. Large bullae encompassing greater than 1\u002F3 of the total lung.\n5. Subject had 3 or more COPD exacerbations requiring hospitalization within 12 months preceding the ICF signature date or a COPD exacerbation requiring hospitalization within 8 weeks of the ICF signature date. Subjects may be re-considered for future enrollment.\n6. Subject has asthma as their primary diagnosis.\n7. Subject has chronic bronchitis (defined as greater than 4 tablespoons of sputum production per day) as their primary diagnosis.\n8. Subject has clinically significant bronchiectasis.\n9. Subjects with evidence of active respiratory infection should be considered for enrollment only after satisfactory resolution.\n10. Subject requires invasive ventilatory support. Note: The use of Continuous Positive Airway Pressure (CPAP) or BiPAP devices for sleep apnea is permitted.\n11. Subject has severe gas exchange abnormalities as defined by any one of the following tests, conducted at rest, on room air, as tolerated.\n\n    * PaCO2 ≥ 50 mm Hg (6.7 kPa)\n    * PaO2 \\\u003C 45 mm Hg (6.0 kPa)\n12. Subject has pulmonary hypertension, defined as mean pulmonary systolic pressure \\> 45 mm Hg.\n13. Subject has known documented alpha-1 antitrypsin deficiency.\n14. Subject has clinically significant hematological disorder.\n15. Subject has recent significant unplanned or unexplained weight loss or other relevant comorbidities considered by the investigator to be potentially confounding or limiting to the subject's participation in the study.\n16. Subject has non-atrial arrhythmias or conduction abnormalities on EKG.\n17. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines (Fleisher 2007) or has ischemic heart disease, congestive heart failure, cerebrovascular disease (stroke or TIA within 6 months of the ICF signature date), serum creatinine \\> 2.0 mg\u002FdL (177 μmol\u002FL), or left ventricular ejection fraction (LVEF) \\\u003C 45% on echocardiogram.\n18. Subject has uncontrolled exercise induced syncope.\n19. Subject has evidence of severe disease which in the judgment of the investigator may compromise the anticipated treatment effect or the subject's survival for the duration of at least 12 months.\n20. Subject has any other condition that the investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject including but not limited to alcoholism, high risk for drug abuse, or noncompliance in returning for follow-up visits.\n21. Subject cannot tolerate corticosteroids or relevant antibiotics.\n22. Subject use of systemic corticosteroids \\> 20 mg\u002Fday prednisolone or equivalent within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment.\n23. Subject use of immunosuppressive agents within four (4) weeks of the ICF signature date. Subjects may be re-considered for future enrollment.\n24. Subject is unable to temporarily discontinue heparins and oral anticoagulants (e.g., warfarin, dicumarol) according to local pre-procedural protocols. Note: Antiplatelet drugs including aspirin, thienopyridines and ticagrelor are permitted.\n25. Subject has allergy or sensitivity to medications required to safely perform bronchoscopy under conscious sedation or general anesthesia.\n26. Subject has known allergy to the following device components: Polyether block amide (PEBAX), Polyvinyl Alcohol or Glutaraldehyde, Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) or Silicone.\n27. Subject is a female who is pregnant (positive βHCG Pregnancy test), breast-feeding, or planning to be pregnant in the next 12 months.\n28. Subject has Body Mass Index \\\u003C 18 kg\u002Fm2 or \\> 35 kg\u002Fm2.\n29. Subject participated in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the ICF signature date. Note: Subjects being followed as part of a long-term surveillance of a non-pulmonary study that has reached its primary endpoint are eligible for participation in this study.","80 Years",{"count":174,"type":21},200,[24],"This is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.",[178,27],"Emphysema, Pulmonary",[180,181,182],"Collateral Ventilation","Bronchoscopic Lung Volume Reduction","Hyperinflation","2026-03-11",{"date":185,"type":36},"2026-03-13",{"date":187,"type":36},"2024-02-22",{"date":189,"type":21},"2028-03-31",{"name":191,"class":79},"Pulmonx Corporation",36,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":200,"targetDuration":202,"studyType":203,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100554939","pimz-longitudinal-cohort-pimz-logic-100554939","NCT06505603","PiMZ Longitudinal Cohort (PiMZ Logic)","Alpha-1 Antitrypsin PiMZ Longitudinal Cohort (PiMZ Logic)","Inclusion Criteria:\n\n1. Males and females aged 18 years and older\n2. Understand the study procedures, risks, benefits, purpose\n3. Able and willing to comply with the study procedures\n4. Have PiMZ alpha-1 antitrypsin deficiency\n5. Post bronchodilator FEV1 \\\u003C 80% predicted AND post bronchodilator FEV1\u002FFVC \\\u003C 70%\n6. Be an existing member of the Alpha-1 Foundation Clinical Cohort (also known as the Alpha-1 Foundation Research Registry)\n7. Agree to have the data collected in this study be shared with the Alpha-1 Foundation Research Registry\n\nExclusion Criteria:\n\n1. AATD non-PiMZ status, including carriers\n2. Current lung, hematologic, or solid organ malignancy other than skin or cervical Stage 1 cancers within the past 3 years\n3. COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit\n4. Pregnancy at the time of the screening visit\n5. Inability to lie still in a supine position for 15 minutes during CT acquisition\n6. Inability to perform quality-controlled lung function testing\n7. Allergy to albuterol\n8. Currently receiving intravenous or subcutaneous immunoglobulin for any disease state\n9. Past or present major surgery on the lungs including pneumonectomy or lobectomy. Wedge resections, past segmentectomy, and pleurodesis surgeries are allowed.\n10. Previous lung or liver transplantation or currently on the transplant list\n11. Decompensated cirrhosis\n12. Current presence of endobronchial coils or valves in the lung\n13. Clinically significant bronchiectasis as defined by the investigator. In general, this would exclude patients with chronic infection of the lungs requiring treatment within the past 6 months including non-tuberculous mycobacterial disease, chronic fungal disease, allergic bronchopulmonary aspergillosis, or known colonization of bronchiectasis with pseudomonas or stenotrophomonas species.\n14. Participation in the active treatment arm of a therapeutic clinical trial at baseline visit unless using one of the Alpha-1 augmentation therapies in alternative doses.\n15. Patient with Automatic Implantable Cardioverter Defibrillator (AICD) and permanent pacemakers (PPM)\n16. Patient receiving biologic immunomodulators that will affect the assessment of the serum biomarkers (as determined by the site PI)\n17. Patient with pleural catheters\n18. Any condition that in the opinion of the investigator might adversely influence the study outcome",{"count":201,"type":21},80,"3 Years","OBSERVATIONAL","Alpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. Presentations are variable in the heterozygous population, the most predominant genotype being PiMZ. The purpose of this study in PiMZ heterozygous patients is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers pertinent to the PiMZ patient that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.",[206,27],"Alpha 1-Antitrypsin Deficiency",[208,209,210],"Alpha-1","Biomarker","PiMZ","2026-01-15",{"date":213,"type":36},"2026-01-16",{"date":215,"type":36},"2025-05-30",{"date":217,"type":21},"2029-02",{"name":219,"class":43},"Columbia University",5,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100324187","phase-1-lung-and-bone-marrow-transplantation-for-lung-and-bone-marrow-failure-100324187","NCT03500731","Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure","Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria in order to be eligible for this study.\n\n1. Subject must be able to understand and provide informed consent.\n2. Male or female, 18 through 60 years old, inclusive, at the time of informed consent.\n3. Meet criteria for UNOS listing for lung transplantation.\n4. Patients must have evidence of end stage lung disease. Examples of such diseases include but are not limited to:\n\n   * Pulmonary Fibrosis\n   * COPD\u002FEmphysema\n5. Patients must have evidence of bone marrow failure with abnormal low cell count in at least one hematopoietic line, making the patient a poor candidate for long-term immunosuppressive therapy. Eligible patients must meet at least one of the following criteria:\n\n   * Unexplained, non-drug induced neutropenia with absolute neutrophils counts of \\\u003C1500\u002FµL the previous year, confirmed by repeat testing\n   * Unexplained, non-drug induced thrombocytopenia with mean platelets counts of \\\u003C100,000\u002FµL the previous year, confirmed by repeat testing\n   * Unexplained, non-hemolytic anemia, with a hemoglobin level of \\\u003C 12 g\u002FdL the previous year, confirmed by repeat testing\n6. GFR ≥45 mL\u002Fmin\u002F1.73 m2.\n7. AST, ALT ≤4x upper limit of normal, total bilirubin ≤ 2.5 mg\u002FdL, normal INR, albumin \\>3.0 g\u002FdL\n8. Cardiac ejection fraction ≥ 40% or shortening fraction ≥26%.\n9. Negative pregnancy test for females, unless surgically sterilized.\n10. All females of childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause birth defect.\n11. Subject will also be counseled regarding the potential risks of infertility following BMT and advised to discuss sperm banking or oocyte harvesting.\n\nExclusion Criteria:\n\nIndividuals who meet any of these criteria are not eligible for this study.\n\n1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n2. Patients who have underlying malignant conditions.\n3. Patients who have non-malignant conditions not requiring BMT.\n4. HIV positive by serology or PCR, HTLV positive by serology. If HTLV serology is positive, it will be confirmed by nucleic acid testing (NAT). If HTLV NAT is negative, subject will remain eligible regardless of HTLV serology result.\n5. Females who are pregnant or who are lactating.\n6. Allergy to DMSO or any other ingredient used in the manufacturing of the stem cell product.\n7. Uncontrolled pulmonary infection, as determined by radiographic findings and\u002For significant clinical deterioration. NOTE: Pulmonary colonization with multiple organisms is common and will not be considered an exclusion criterion.\n8. Uncontrolled infection, as determined by the appropriate imaging and\u002For confirmatory testing e.g. blood cultures, PCR testing, etc.\n9. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of transplant.\n10. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.","60 Years",{"count":230,"type":21},8,[232,233],"PHASE1","PHASE2","The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.",[236,27],"Idiopathic Pulmonary Fibrosis",[238,239,236,27,240,241,242,243,244,245,246,247],"Lung Transplantation","Stem Cell Transplantation","Bone marrow transplantation","Cadaveric donor","Unrelated donor","HLA-Mismatch","BMT","HSCT","IPF","Pulmonary fibrosis","2026-01-12",{"date":250,"type":36},"2026-01-13",{"date":252,"type":36},"2018-04-19",{"date":254,"type":21},"2028-12",{"name":256,"class":43},"Paul Szabolcs",2,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":265,"maxAge":125,"enrollmentInfo":266,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":279,"locationsCount":4},"100576693","utilising-hull-lung-health-study-data-to-investigate-the-performance-of-tidalsense-diagnostic-algorithms-to-identify-copd-and-pre-copd-among-participants-in-the-frontier-programme-100576693","NCT06788613","Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme.","Beyond-FRONTIER: Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme","All Hull Lung Health Study participants that attend a one-stop diagnostic clinic appointment as part of the FRONTIER Programme (NHS Lung Health Check) will be eligible for inclusion in this study.\n\nProspective consent provided for use of data for research purposes and for future contact as part of the Hull Lung Health Study\n\nInclusion criteria:\n\n* Participants in the Hull Lung Health Check Programme (ever smokers aged 55-75 and registered with a Hull GP) with one or more of the following symptoms during their lung health check:\n* Breathlessness\n* Cough\n* Bronchitis\n* Recurrent infections\n* AND\u002FOR evidence of Emphysema on Low Dose CT\n\nExclusion criteria:\n\n-Existing COPD diagnosis noted at the time of their Lung Health Check or new COPD diagnosis since Lung Health Check attendance AND prescribed appropriate COPD therapy.","55 Years",{"count":267,"type":21},1200,"Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD\\*.\n\nObjectives:\n\n1. To assess the performance of TidalSense COPD Diagnostic Algorithms for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants.\n2. To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.\n3. Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year.\n\nAim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.\n\nObjectives:\n\n1. Investigate the blood biomarker profile (obtained from the Hull Lung Health Study data) of people with i) confirmed COPD, ii) pre-COPD, and iii) no evidence of COPD.\n2. Explore a potential role for blood biomarkers in COPD diagnostics.\n\n   * Pre-COPD is defined, as per the GOLD Report 2023, as individuals who have respiratory symptoms and\u002For other detectable structural and\u002For functional abnormalities in the absence of airflow obstruction on forced spirometry. For the purpose of this study, respiratory symptoms will be classified as a CAT score \\> 10 during FRONTIER clinic attendance and presence of emphysema on low-dose CT considered evidence of structural lung abnormalities",[58,27,57],[58,271,272,273],"Hull Lung Health","TidalSense","N-tidal",{"date":275,"type":36},"2025-05-31",{"date":277,"type":21},"2025-08",{"date":112,"type":21},{"name":280,"class":79},"Chiesi UK",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100566457","the-reduce-eu-study---endobronchial-thermal-liquid-ablation-etla-for-the-treatment-of-emphysema-100566457","NCT06655428","The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema","The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)","Inclusion Criteria:\n\n* Age ≥ 40 years old\n* Diagnosis of COPD with FEV1\u002FFVC less than 0.7 post-bronchodilation\n* Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value\n* Total lung capacity (TLC) ≥ 100% predicted\n* Residual volume (RV) ≥ 175% predicted\n* 6 Minute Walk Distance (6MWD) ≥ 140 meters\n* Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)\n* Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air\n* Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator\n* Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing\n* Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation\n* Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure\n* Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal\n* Cognitively able to provide written informed consent and willing to comply with study requirements\n* Severe emphysematous lung subsegments eligible for ETLA treatment\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 16 kg\u002Fm\\^2 or ≥ 33 kg\u002Fm\\^2\n* DLCO \\\u003C 20% predicted\n* Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms\n* 75ml or greater sputum production per day most days of the week\n* Greater than two hospitalizations for COPD exacerbations and\u002For pneumonia in the 12 months prior to enrollment\n* Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines\n* Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and\u002For polymer. Patients whose valves have been removed \\> 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.\n* Pulmonary hypertension\n* Alpha-1 antitrypsin deficiency\n* Uncontrolled diabetes mellitus\n* Prior heart or lung transplant\n* Myocardial infarction or stroke within the 12 months of enrollment\n* Diagnosis of heart failure\n* Heart failure requiring hospitalization, within 6 months prior to enrollment\n* History of bleeding disorders or enhanced predisposition to bleeding\n* History of severe\u002Fmassive hemoptysis defined as \\>200ml of blood loss in \\\u003C 24 hours\n* Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid \\[ASA\\]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure\n* Daily systemic steroids equivalent to \\> 15mg prednisolone\n* Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue\u002Forgan rejection\n* Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration\n* Currently enrolled in another trial studying an experimental treatment\n* Any disease or condition likely to limit survival to less than one year\n* Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA\n* Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.\n* Active aspergillus infection\n* Clinically significant bronchiectasis as determined by the Investigator\n* Radiological evidence of bronchiectasis in target region(s) and\u002For cystic radiological bronchiectasis in any region of the lungs\n* Clinically significant pulmonary fibrosis\n* Lung nodule not proven stable unless proven to have benign pathology\n* Large bulla (defined as \\> 1\u002F3 volume of a lung)\n* Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy\n* The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased\n* Active respiratory infection or recent respiratory infection with resolution \\\u003C 4 weeks prior to screening or procedure\n* Recent COPD exacerbation within \\\u003C 6 weeks prior to screening or procedure",{"count":289,"type":21},30,[24],"The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety.\n\nParticipants will:\n\n* Have up to two ETLA procedures\n* Complete five clinic follow-up visits and two virtual follow-up visits.",[27,57,178,58,293],"COPD (Chronic Obstructive Pulmonary Disease)",[295,296,297,298,299,300,132,301],"Lung Volume Reduction","bronchoscopic lung volume reduction","ETLA","BTVA","LVR","Lung Disease, obstructive","Respiratory Tract Disease","2025-01-27",{"date":304,"type":36},"2025-01-28",{"date":306,"type":36},"2025-01-10",{"date":308,"type":21},"2026-05",{"name":310,"class":79},"Morair Medtech, LLC",7,{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":319,"targetDuration":321,"studyType":203,"phases":4,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":127},"100310210","post-market-btva-registry-100310210","NCT03318406","Post-Market BTVA Registry","Post-Market Registry for Patients With Emphysema Treated With BTVA","Inclusion Criteria:\n\n1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index \\> or equal to 1.2 in at least one segment to be treated\n2. Patients must be \\> or equal to 18 years of age\n3. Patients are required to provide informed consent prior to inclusion in the Registry\n\nExclusion Criteria:\n\n1. FEV1 \\\u003C 20% predicted\n2. DLCO \\\u003C 20% predicted\n3. Inability to walk \\> 140 meters in 6 minutes (6MWD) following optimized medical management\n4. Unstable COPD (any of the following):\n\n   1. \\> 3 COPD related hospitalizations requiring antibiotics in past 12 months\n   2. COPD related hospitalization in past 3 months\n   3. daily use of systemic steroids, i.e. \\> 5 mg prednisolone\n5. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency\n6. Newly prescribed morphine derivatives within the last 4 weeks\n7. Pregnant or breastfeeding\n8. Highly diseased lower lobes (tissue to air ratio of \\\u003C11%)\n9. Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)\n10. Presence of single large bulla (defined as \\> 1\u002F3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe\n11. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -",{"count":320,"type":21},300,"5 Years","Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.",[27],[325,326,327,298],"registry","vapor ablation","InterVapor","2025-01-25",{"date":304,"type":36},{"date":331,"type":36},"2018-03-22",{"date":333,"type":21},"2030-12-01",{"name":335,"class":79},"Uptake Medical Technology, Inc.",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":115},"100539466","telehealth-and-onsite-maintenance-exercise-in-chronic-lung-disease-100539466","NCT06304207","Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease","Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease: A Pilot Randomized Controlled Trial","CLD","Inclusion Criteria:\n\n* All adult patients 40 years and older with physician diagnosed Chronic Lung Disease within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition\n* Able to walk independently with or without mobility devices\n* Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85%\n* Able to follow commands and instructions in the English language\n* Have ability to connect to the internet\n\nExclusion Criteria:\n\n* • Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device.\n\n  * Patients who primarily rely on a wheelchair for mobility\n  * Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation\n  * Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs)\n  * Inability to communicate in the English language",{"count":289,"type":21},[24],"The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease.\n\nThe specific aims of the study are:\n\n* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.\n* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation.\n\nParticipants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.",[348,349,350,27,351,352,95,353,354,355],"Copd","COPD Exacerbation","COPD Bronchitis","Chronic Lung Disease","Pulmonary Fibrosis","Bronchiectasis","Chronic Asthma","Chronic Asthmatic Bronchitis","2024-07-30",{"date":358,"type":36},"2024-08-01",{"date":360,"type":36},"2023-09-01",{"date":362,"type":21},"2026-03-01",{"name":364,"class":43},"MGH Institute of Health Professions",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":115},"100378979","biological-investigation-of-explanted-endobronchial-lung-valves-study-100378979","NCT04214587","Biological Investigation of Explanted Endobronchial Lung Valves Study","Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions","Bio-EXCEL","Inclusion Criteria:\n\n* Elidgible for EBV treatment\n\nExclusion Criteria:\n\n* Anticoagulation which cannot be stopped prior to the procedure",{"count":374,"type":21},150,"Rationale:\n\nCOPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone\u002Fnitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.\n\nObjective:\n\nThe main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.",[27],"2024-06-13",{"date":379,"type":36},"2024-06-14",{"date":381,"type":36},"2021-03-16",{"date":383,"type":21},"2027-03-02",{"name":385,"class":43},"University Medical Center Groningen",{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":203,"phases":4,"briefSummary":394,"conditions":395,"keywords":396,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":115},"100528619","the-effect-of-treatment-of-emphysema-with-endobronchial-valves-on-the-diaphragm-mobility-100528619","NCT06163131","The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility","Inclusion Criteria:\n\n1. Patients selected to receive treatment with endobronchial valves\n2. Signed informed consent\n\nExclusion Criteria:\n\n1. Neuromuscular disease interfering with diaphragm function\n2. Pleural effusion at time of preoperative or 90-days postoperative ultrasound",{"count":393,"type":21},35,"In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness.\n\nThe goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are:\n\n* If the movement of the diaphragm improves after treatment with endobronchial valves.\n* If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability.\n* If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment.\n\nParticipants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.",[98,27],[101,397,156,398],"Diaphragm","Endobronchial Lung Volume Reduction","2023-11-30",{"date":401,"type":36},"2023-12-08",{"date":403,"type":21},"2023-11-27",{"date":405,"type":21},"2027-04-01",{"name":407,"class":43},"Aarhus University Hospital"]