Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
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).
Official title: A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD
Key Details
Gender
All
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2025-09-01
Completion Date
2027-02-01
Last Updated
2025-09-02
Healthy Volunteers
No
Interventions
Pulse 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.
Sham 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