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RECRUITING
NCT07068438
NA

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

Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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