NCT07068438

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Bronchitis
• COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2025-07-16
• Last updated: 2025-09-02

Locations

13 sites across 1 country: China