Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD

Trial details

Who runs it

Hangzhou Broncus Medical Co., Ltd.

Trial code

NCT05799664

Record updated

2026. szeptember 30.

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Participants aged ≥40 and ≤ 85 years; Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg; CAT ≥ 10 or mMRC ≥2; Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation; 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; Documented history of taking standard medication (consistent with GOLD guideline<2022>) for ≥12 months at the time of consent; 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; Resting SpO2 ≥ 89% at the time of screening; Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary; Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.

Exclusion: Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis); Patient has a medical history of pneumothorax within 6 months before the screening visit; Malignancy treated with radiation or chemotherapy within 2 years of consent; Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas; Previous or planned pulmonary or thoracic surgery (including pneumonectomy, lung transplantation, bronchoscopic/interventional lung volume reduction procedures < e.g. endobronchial valve implantation or bronchial thermal vapor ablation, etc.>) during this trial; 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 (> 1/3 hemithorax) or site discovery of a mass that requires treatment; A GCSI total symptom score ≥ 18.0 prior to treatment; Participated in any clinical trial and received experimental treatment within 3 months before the screening visit; Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled; Recent respiratory infections or COPD exacerbation in preceding 4 weeks; High risk of pulmonary hypertension according to clinical assessment, defined as pulmonary artery systolic pressure estimated by echocardiogram to be > 50 mmHg; A lesion highly suspicious for malignancy in the lung or elsewhere, as determined by a specialist, that is expected to require surgery or systemic anticancer therapy within 1 year; Myocardial infarction within last 6 months, EKG with evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF < 45%, stage C or D (ACC/AHA) 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; Any disease or condition that might interfere with completion of a procedure or this study (e.g., life expectancy< 1 years); BMI < 18 or > 35; Asthma as defined by the GINA guideline (2022); Daily use of > 10 mg of prednisone or its equivalent at the time of consent; Recent (within 3 months of consent) opioid use; Has an implantable electronic device; 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; 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.

ClinicalTrials.gov NCT05799664