Actively Recruiting
A Clinical Evaluation of the Pulsed Electric Field Ablation System for Treating Chronic Bronchitis Symptoms in Adults with COPD
Led by Suzhou Hengruihongyuan Medical Technology Co. LTD · Updated on 2025-09-02
210
Participants Needed
13
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a pulsed electric field ablation system developed by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for treating symptoms of chronic bronchitis in adults with moderate to severe chronic obstructive pulmonary disease (COPD). This prospective, randomized, sham-controlled, multicenter clinical trial will include 210 patients, who will be assigned to either the treatment group or a sham procedure group in a 2:1 ratio. The treatment involves a staged bronchial rheoplasty procedure where pulsed electric fields are applied first to the right lung and then the left lung about one month later. Patients in the sham group will undergo a similar staged procedure without the energy delivery. The study will monitor patients over various time points up to 12 months to assess treatment effects. Participants will undergo several assessments including the COPD Assessment Test (CAT) score, St. George Respiratory Questionnaire (SGRQ-C), dyspnea scales, pulmonary function tests (FEV1 and FEV1/FVC ratio), and a six-minute walking test. Evaluations occur at 3, 6, and 12 months after treatment. The study also measures the rate of COPD exacerbations and technical success of the procedure shortly after device removal. Safety and adherence are monitored throughout the study duration, which extends up to 12 months post-treatment.
CONDITIONS
Brief Title
Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 35 and 80 years
- Diagnosed with chronic bronchitis, defined as productive cough for at least three months in two consecutive years
- COPD Assessment Test (CAT) score of 10 or higher
- St. George Respiratory Questionnaire (SGRQ) score of 25 or higher
- Sum of first two CAT questions score 7 or more, or sum 6 with total CAT score over 20
- FEV1/FVC ratio less than 0.70
- Pre-procedure post-bronchodilator FEV1 at least 30% predicted
- Receiving guideline-directed pharmacotherapy including long acting bronchodilator(s) for at least 8 weeks unless prior attempt ineffective or adverse
- Able to undergo two bronchoscopies under general anesthesia and comply with follow-up
- Provided signed informed consent
You will not qualify if you...
- Known unresolved lower respiratory tract infection
- Steroid-dependent condition requiring more than 10 mg oral corticosteroids daily
- Implantable electronic device that cannot be turned off during procedure
- History of significant arrhythmias in past two years or low heart rate unless treated
- Lung cancer diagnosis
- Pulmonary nodule or cavity needing potential intervention
- Prior lung surgery or lung implants
- Emphysema affecting 50% or more of lungs
- Asthma diagnosis
- Clinically significant bronchiectasis affecting symptoms
- Active smoking or vaping within last 2 months
- Unable to walk more than 225 meters in 6 minutes
- Serious medical conditions that could compromise safety or affect results
- Uncontrolled gastroesophageal reflux disease (GERD)
- Severe pulmonary hypertension (pulmonary artery systolic pressure 50 mmHg or higher)
- Known sensitivity to bronchoscopy medications
- Pregnant, nursing, or planning pregnancy during study
- Participation in another investigational clinical study
- Unable to suspend anticoagulant medications during procedure
- Airway colonization with drug-resistant bacteria or significant fungi infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month between two treatment visits
Participants undergo a staged pulsed electric field ablation procedure or a staged sham procedure, with treatment of the right lung first followed by the left lung approximately 1 month later.
2 treatment visits (in-person)
Duration - Up to 12 months
Participants are monitored for treatment effects and safety outcomes including lung function, COPD symptoms, and exercise capacity.
Visits at 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 13 locations
1
Anhui Chest Hospital
Hefei, Anui, China, 230022
Not Yet Recruiting
2
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
3
Hospital Emergency General
Beijing, Beijing Municipality, China, 100028
Not Yet Recruiting
4
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213003
Not Yet Recruiting
5
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215005
Not Yet Recruiting
6
The Second People's Hospital of Wuxi
Wuxi, Jiangsu, China, 214002
Not Yet Recruiting
7
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China, 221006
Not Yet Recruiting
8
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
9
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
10
Jinhua Central Hospital
Jinhua, Zhejiang, China, 321000
Not Yet Recruiting
11
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
12
Quzhou People's Hospital
Quzhou, Zhejiang, China, 324000
Not Yet Recruiting
13
Shaoxing People's Hospital
Shaoxing, Zhejiang, China, 312000
Not Yet Recruiting
Research Team
E
Enguo Chen
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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