RecruitingNot ApplicableNCT07068438

Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease

A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD


Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Enrollment

210 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 35 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new procedure called pulsed electric field (PEF) ablation — which uses targeted electrical pulses delivered through a bronchoscope (a thin tube passed into the airways) to destroy mucus-producing glands — to reduce chronic cough and phlegm in people with COPD. **You may be eligible if...** - You are 35 to 80 years old and have COPD with chronic bronchitis (cough and phlegm for at least 3 months per year, 2 years in a row) - Your symptoms score high on standard COPD questionnaires (CAT and SGRQ) - You are already on standard COPD medications including a long-acting bronchodilator - You are able to have two bronchoscopies under general anesthesia - You have not smoked in the past 2 months **You may NOT be eligible if...** - You have an active lung infection or lung cancer - You have a pacemaker or implanted electronic heart device - You have had prior lung surgery, lung valve placement, or significant emphysema - You have uncontrolled heart disease, GERD, or severe pulmonary hypertension - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulse electric field ablation system

Bronchial rheoplasty (BR) is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.

DEVICESham Procedure

Staged sham procedure: the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient).


Locations(13)

Anhui Chest Hospital

Hefei, Anui, China

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Hospital Emergency General

Beijing, Beijing Municipality, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Second People's Hospital of Wuxi

Wuxi, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Jinhua Central Hospital

Jinhua, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Quzhou People's Hospital

Quzhou, Zhejiang, China

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07068438


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