Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease (NCT07068438) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
China210 participantsStarted 2025-09-01
Plain-language summary
This is a prospective, randomized, parallel group, sham-controlled, multicenter clinical trial. The objective is to evaluate the safety and effectiveness of pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 210 patients will be randomized into the experimental group and the sham group (2:1).
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject's age is ≥35 years and ≤80 years.
. Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
. Patient has a CAT score ≥ 10.
. Patient has an SGRQ score ≥ 25.
. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is \> 20 points.
. Patient has FEV1/FVC \< 0.70.
. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
COPD Assessment Test (CAT) Score
Timeframe: 6 months
Trial details
NCT IDNCT07068438
SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD
. Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
Exclusion criteria
. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
. Patient has a steroid-dependent condition requiring \>10 mg of oral corticosteroid per day.
. Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
. Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, or sinus bradycardia with a heart rate of under than 45 beats per minute, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
. Subject has lung cancer.
. Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
. Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan as determined by the CT Core Lab.