[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"emphysema-pulmonary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:emphysema-pulmonary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100518790","an-evaluation-of-the-aeriseal-system-for-converting-collateral-ventilation-status-in-patients-with-severe-emphysema-100518790",false,"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.","ALL","40 Years","80 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Emphysema, Pulmonary","Emphysema or COPD",[31,32,33],"Collateral Ventilation","Bronchoscopic Lung Volume Reduction","Hyperinflation","RECRUITING","2026-03-11",{"date":37,"type":38},"2026-03-13","ACTUAL",{"date":40,"type":38},"2024-02-22",{"date":42,"type":22},"2028-03-31",{"name":44,"class":45},"Pulmonx Corporation","INDUSTRY",36,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"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":55,"type":22},30,[25],"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.",[29,59,28,60,61],"Emphysema","COPD","COPD (Chronic Obstructive Pulmonary Disease)",[63,64,65,66,67,68,69,70],"Lung Volume Reduction","bronchoscopic lung volume reduction","ETLA","BTVA","LVR","Lung Disease, obstructive","Chronic Obstructive Lung Disease","Respiratory Tract Disease","2025-01-27",{"date":73,"type":38},"2025-01-28",{"date":75,"type":38},"2025-01-10",{"date":77,"type":22},"2026-05",{"name":79,"class":45},"Morair Medtech, LLC",7]