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
Suzhou Hengruihongyuan Medical Technology Co. LTD
210 participants
Sep 1, 2025
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
Plain Language Summary
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Interventions
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.
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)
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NCT07068438