Study of Pulsed Electric Field Ablation System to Treat Chronic Bronchitis Symptoms in Adults with COPD Aged 35 to 80 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a pulsed electric field ablation system developed by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for treating symptoms of chronic bronchitis in adults with moderate to severe chronic obstructive pulmonary disease COPD. This prospective, randomized, sham-controlled, multicenter clinical trial will include 210 patients, who will be assigned to either the treatment group or a sham procedure group in a 21 ratio. The treatment involves a staged bronchial rheoplasty procedure where pulsed electric fields are applied first to the right lung and then the left lung about one month later. Patients in the sham group will undergo a similar staged procedure without the energy delivery. The study will monitor patients over various time points up to 12 months to assess treatment effects. Participants will undergo several assessments including the COPD Assessment Test CAT score, St. George Respiratory Questionnaire SGRQ-C, dyspnea scales, pulmonary function tests FEV1 and FEV1FVC ratio, and a six-minute walking test. Evaluations occur at 3, 6, and 12 months after treatment. The study also measures the rate of COPD exacerbations and technical success of the procedure shortly after device removal. Safety and adherence are monitored throughout the study duration, which extends up to 12 months post-treatment.

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