Actively Recruiting
Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD
Led by Hangzhou Broncus Medical Co., Ltd. · Updated on 2024-01-24
200
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 40 to 75 years
- Diagnosed with COPD with post-bronchodilator lung function showing FEV1/FVC <70% and FEV1 between 20% and 60% of predicted; if FEV1 is less than 30% predicted, PaCO2 must be 50mmHg or less
- COPD Assessment Test (CAT) score of 10 or higher or Modified Medical Research Council (mMRC) dyspnea scale of 2 or higher
- Non-smoking for at least 2 months prior to consent and agree not to smoke during the study
- Participation in a formal pulmonary rehabilitation program at least 3 months before consent or current enrollment with agreement to continue through 12-month follow-up
- History of taking standard COPD medication consistent with GOLD guidelines for at least 12 months before consent
- Received influenza vaccine within 12 months prior to consent or agree to receive one during the study and annually thereafter
- Resting blood oxygen saturation (SpO2) of 89% or higher at screening
- Willing and able to complete all required baseline and follow-up assessments including patient diary
- Able to understand the study purpose, agree to participate, and provide informed consent
You will not qualify if you...
- Body mass index (BMI) less than 18 or greater than 35
- Diagnosis of asthma as defined by GINA guidelines
- Diagnosed with any non-COPD active lung disease such as active tuberculosis
- History of pneumothorax
- Known allergy or contraindication to medications needed for bronchoscopy or general anesthesia that cannot be controlled
- Recent respiratory infection or COPD exacerbation within the past 4 weeks
- Cancer treated with radiation or chemotherapy within 2 years prior to consent
- Daily use of more than 10 mg prednisone or equivalent at consent
- Opioid use within 3 months before consent
- Known gastrointestinal motility disorder or previous surgery on stomach, esophagus, or pancreas
- Presence of implantable electronic device
- Previous or planned pulmonary or thoracic surgery during the trial
- Recent myocardial infarction, serious heart rhythm problems, low heart function, or severe heart failure making procedure unsafe
- High risk of pulmonary hypertension with estimated pulmonary artery pressure above 50 mmHg
- Pulmonary nodules or lesions considered highly suspicious for cancer
- Severe bronchiectasis with symptoms such as cough and repeated coughing up of blood
- Severe emphysema or airway anatomy preventing use of TLD device
- Gastroparesis symptom score of 18 or higher before treatment
- Any disease or condition likely to interfere with study completion or with life expectancy less than one year
- Women of childbearing potential must have negative pregnancy test and agree to avoid pregnancy during the study
- Participation in another clinical trial with experimental treatment within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Liheng Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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