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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
210
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).
Anhui Chest Hospital
Hefei, Anui, China
NOT_YET_RECRUITINGAffiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHospital Emergency General
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First People's Hospital of Changzhou
Changzhou, Jiangsu, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGThe Second People's Hospital of Wuxi
Wuxi, Jiangsu, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGJinhua Central Hospital
Jinhua, Zhejiang, China
NOT_YET_RECRUITING...and 3 more locations
COPD Assessment Test (CAT) Score
Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden
Time frame: 6 months
COPD Assessment Test (CAT) score
Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden.
Time frame: 3 and 12 months
COPD Assessment Test (CAT) Score (items 1 and 2)
Mean change from baseline in mean total scores for items 1 and 2 of the bilateral CAT scores (ranges from 0 to 10), where lower scores represent lower symptom burden.
Time frame: 3, 6 and 12 months
St. George Respiratory Questionnaire (SGRQ-C)
Change from baseline in the total score of the COPD of the St. George Respiratory Questionnaire (SGRQ-C), the total score ranges from 0 to 100, where lower scores represent lower symptom burden.
Time frame: 6 and 12 months
Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores
Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores, rated on a scale from 0 to 4, where lower grades represent lower symptom burden.
Time frame: 3, 6 and 12 months
COPD Exacerbations
Rate of moderate and severe COPD exacerbations.
Time frame: 12 months
Pulmonary Function (FEV1)
Changes from baseline in forced expiratory volume in the first second (FEV1) during a pulmonary function test (PFT).
Time frame: 3, 6 and 12 months
Pulmonary Function (FEV1 /FVC ratio)
Changes from baseline in the FEV1 /FVC ratio during a pulmonary function test (PFT).
Time frame: 3, 6 and 12 months
The six minute walking test (6MWT)
Change from baseline in the 6-minute walk test.
Time frame: 6 and 12 months
Technical success rate
Success defined as: * Experimental group: Successful placement of the device, successful discharge, and successful withdrawal. * Control group: Successful placement of the device, and successful withdrawal. Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%.
Time frame: Approximately 15-minutes after device removal
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