Actively Recruiting
Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
Led by Suzhou Hengruihongyuan Medical Technology Co. LTD · Updated on 2025-09-02
210
Participants Needed
13
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Chronic bronchitis defined as productive cough for three months in each of two consecutive years with other causes ruled out
- COPD Assessment Test (CAT) score of 10 or higher
- St. George's Respiratory Questionnaire (SGRQ) score of 25 or higher
- Sum of first two CAT questions of 7 or more points, or 6 points with total CAT score above 20
- FEV1/FVC ratio less than 0.70
- Pre-procedure post-bronchodilator FEV1 predicted percentage of 30% or more
- Receiving guideline-based pharmacotherapy including one or more long-acting bronchodilators for at least 8 weeks unless prior therapy attempts were unsuccessful or caused adverse reactions
- Able to undergo two bronchoscopies under general anesthesia and adhere to follow-up schedule
- Provided informed consent
You will not qualify if you...
- Known unresolved lower respiratory tract infection such as pneumonia, MAI infection, fungus, or tuberculosis
- Steroid-dependent condition requiring more than 10 mg of oral corticosteroids daily
- Presence of implantable electronic devices that cannot be turned off during the procedure
- History of significant heart rhythm disorders in the past two years or very slow heart rate unless treated and stable
- Diagnosis of lung cancer
- Pulmonary nodules or cavities possibly requiring intervention
- Prior lung surgeries including transplant, lobectomy, or lung implants
- Emphysema affecting 50% or more of the lungs on baseline scan
- Asthma diagnosis based on Global Initiative for Asthma criteria
- Significant bronchiectasis affecting cough and phlegm symptoms
- Active smoking or use of tobacco, marijuana, e-cigarettes, or vaping within last 2 months
- Inability to walk more than 225 meters in 6 minutes
- Serious medical conditions that may affect safety or study results such as heart failure, recent heart attack, renal or liver failure, recent stroke, uncontrolled diabetes or hypertension, or autoimmune diseases needing immunosuppressants
- Uncontrolled gastroesophageal reflux disease
- Severe pulmonary hypertension
- Known sensitivity to medications used in bronchoscopy
- Pregnant, nursing, or planning pregnancy during study
- Participation in another investigational study
- Use of anticoagulants that cannot be safely paused during bronchoscopy
- Known airway colonization with drug-resistant bacteria or significant fungi
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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