A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD
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).
• Subject's age is ≥35 years and ≤80 years.
• Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
• Patient has a CAT score ≥ 10.
• Patient has an SGRQ score ≥ 25.
• Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is \> 20 points.
• Patient has FEV1/FVC \< 0.70.
• Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
• Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
• In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule.
⁃ Informed consent signed by the patient or legal representative.