Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease
Recruiting
N/A
Interventional Study
Chronic Bronchitis
COPD (Chronic Obstructive Pulmonary Disease)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 35 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 210 (estimated)
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subject's age is ≥35 years and ≤80 years.
2. 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.
3. Patient has a CAT score ≥ 10.
4. Patient has an SGRQ sco…
Contacts