[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Broncus Medical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100555663","evaluation-of-the-feasibility-safety-and-efficacy-of-single-use-endobronchial-silicon-spigots-for-the-treatment-of-refractory-pneumothorax-100555663",false,"NCT06515015","Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax","Exploratory, Single-Group, Single-Center Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled:\n\n  1. Male or female, aged ≥18 years;\n  2. Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days;\n  3. After evaluation by the researcher, the subject is feasible for the bronchoscopic procedure of selective bronchial occlusion to treat refractory pneumothorax, and the responsible bronchus can be determined by the balloon detection;\n  4. Voluntarily participate in this trial and sign an informed consent form.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions cannot be selected:\n\n  1. Allergic to silicone materials;\n  2. Contraindications for bronchoscopy:\n\n     * Myocardial infarction within the past month;\n     * Active massive hemoptysis;\n     * Platelet count \\\u003C20×10\\^9\u002FL;\n     * Pregnancy;\n     * Malignant arrhythmias, unstable angina, severe cardiopulmonary dysfunction, hypertensive crisis, severe pulmonary arterial hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness, and extreme systemic exhaustion, etc.\n  3. Uncontrolled acute pulmonary infection or severe chronic infection at the intended occlusion lobes or segments;\n  4. Obvious hemodynamic instability or unstable respiratory failure;\n  5. The responsible bronchus cannot be determined by balloon detection;\n  6. The researcher believes that the patient has other conditions that are not suitable for inclusion in this study.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","Study Objective: To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the development and clinical application of bronchial occlusion.\n\nStudy Population: Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax.\n\nSample Size: This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax. The sample size has not been strictly calculated, and it is expected to include 10 patients.\n\nStudy Design: This study is an exploratory, single-group, single-center clinical study.",[26],"Pneumothorax",[26,28,29,30],"spigots","air leakage","bronchial occlusion","RECRUITING","2024-08-14",{"date":34,"type":35},"2024-08-15","ACTUAL",{"date":37,"type":20},"2024-08",{"date":39,"type":20},"2026-08",{"name":41,"class":42},"Hangzhou Broncus Medical Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":43},"100500700","evaluation-of-safety-and-effectiveness-of-tld-radiofrequency-ablation-in-the-treatment-of-copd-100500700","NCT05799664","Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD","A Multicenter, Randomized, Single-blind, Sham-controlled Clinical Trial to Evaluate the Safety and Effectiveness of Targeted Lung Denervation Radiofrequency Ablation Devices in the Treatment of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Participants aged ≥40 and ≤ 75 years;\n2. Diagnosis of COPD with post-bronchodilator PFT parameters FEV1\u002FFVC\\\u003C70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1\\\u003C30%pred, PaCO2≤50mmHg;\n3. CAT ≥ 10 or mMRC ≥2;\n4. Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;\n5. Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participants are currently enrolled in a maintenance program, they should agree to continue their current program through their 12-month follow-up visit;\n6. Documented history of taking standard medication (consistent with GOLD guideline\\\u003C2022\\>) for ≥12 months at the time of consent;\n7. Received an influenza vaccine within the 12 months prior to consent or agrees to obtain an influenza vaccine during the clinical investigation, and agrees to annual influenza vaccines for the duration of the clinical investigation;\n8. Resting SpO2 ≥ 89% at the time of screening;\n9. Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary;\n10. Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.\n\nExclusion Criteria:\n\n1. BMI \\\u003C 18 or \\> 35;\n2. Asthma as defined by the GINA guideline (2022);\n3. Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);\n4. Patient has a medical history of pneumothorax;\n5. Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled;\n6. Recent respiratory infections or COPD exacerbation in preceding 4 weeks;\n7. Malignancy treated with radiation or chemotherapy within 2 years of consent;\n8. Daily use of \\> 10 mg of prednisone or its equivalent at the time of consent;\n9. Recent (within 3 months of consent) opioid use;\n10. Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas\n11. Has an implantable electronic device;\n12. Previous or planned pulmonary or thoracic surgery (including but not limited to: pneumonectomy, lung transplantation, pulmonary medical device intervention \\\u003C e.g. pulmonary valve implantation, bronchial thermal ablation (BT), etc. \\>) during this trial;\n13. Myocardial infarction within last 6 months, EKG with evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \\\u003C 45%, stage C or D (ACC\u002FAHA) or Class III or IV (NYHA) congestive heart failure, or any other cardiac findings that make the participant an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia;\n14. High risk of pulmonary hypertension according to clinical assessment, defined as pulmonary artery systolic pressure estimated by echocardiogram to be \\> 50 mmHg;\n15. Pulmonary nodule or other lesions thought to be at high risk of malignancy;\n16. Clinically relevant bronchiectasis, defined as severe single lobe or multilobar bronchial wall thickening associated with airway dilation on CT scan leading to cough, intractable expectoration and repeated hemoptysis lasting for several days;\n17. In the opinion of the Investigator, use of the TLD devices is not feasible, for example, due to screening chest CT scan reveals severe emphysema or bronchi anatomy cannot be fully treated with available catheter sizes: severe bullous disease (\\> 1\u002F3 hemithorax) or site discovery of a mass that requires treatment;\n18. A GCSI total symptom score ≥ 18.0 prior to treatment;\n19. Any disease or condition that might interfere with completion of a procedure or this study (e.g., life expectancy\\\u003C 1 years);\n20. Women of childbearing potential must have a negative pregnancy test (blood or urine) pre-treatment and agree not to become pregnant for the duration of the study\n21. Participated in any clinical trial and received experimental treatment within 3 months before the screening visit.","40 Years","75 Years",{"count":54,"type":20},200,[23],"The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.",[58],"COPD","2024-01-23",{"date":61,"type":35},"2024-01-24",{"date":63,"type":35},"2023-07-04",{"date":39,"type":20},{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},"100520094","transbronchial-vs-transthoracic-ablation-for-early-stage-peripheral-lung-cancer-100520094","NCT06052098","Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer","Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age greater than 18 years.\n2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.\n3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.\n4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with platelet \\\u003C 50 × 10 9\u002FL, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.\n2. Patients with severe pulmonary fibrosis and pulmonary hypertension.\n3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \\> 38.5℃.\n4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.\n5. Patients with poorly controlled malignant pleural effusion.\n6. Anticoagulation therapy and\u002For antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\\~7 days before ablation.\n7. Eastern Cooperative Oncology Group (ECOG) score \\> 2.\n8. Combined with other tumors with extensive metastasis, expected survival \\\u003C 6 months.\n9. Patients with episodic psychosis.\n10. Patients with implantable electronic devices (such as pacemaker or defibrillator).\n11. Pregnant women, or patients who have pregnancy plans during the study.\n12. Participation or ongoing participation in another clinical study within the past 30 days.\n13. Other situations that the investigator deems inappropriate to participate in this study.",{"count":74,"type":20},110,[23],"The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.",[78],"Stage IA Lung Cancer","2023-11-30",{"date":81,"type":35},"2023-12-06",{"date":83,"type":35},"2023-10-11",{"date":85,"type":20},"2027-10",{"name":41,"class":42},""]