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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Electric Field Ablation System | Experimental |
| |
| Sham Procedure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse electric field ablation system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 and 12 months |
| COPD Assessment Test (CAT) Score (items 1 and 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enguo Chen | Contact | +86 13588706779 | cheneg@srrsh.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Not yet recruiting | Hefei | Anui | 230022 | China |
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| Sham Procedure | Device | 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). |
|
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. |
| 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. | 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. | 3, 6 and 12 months |
| COPD Exacerbations | Rate of moderate and severe COPD exacerbations. | 12 months |
| Pulmonary Function (FEV1) | Changes from baseline in forced expiratory volume in the first second (FEV1) during a pulmonary function test (PFT). | 3, 6 and 12 months |
| Pulmonary Function (FEV1 /FVC ratio) | Changes from baseline in the FEV1 /FVC ratio during a pulmonary function test (PFT). | 3, 6 and 12 months |
| The six minute walking test (6MWT) | Change from baseline in the 6-minute walk test. | 6 and 12 months |
| Technical success rate | Success defined as:
Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%. | Approximately 15-minutes after device removal |
| Affiliated Beijing Chaoyang Hospital of Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
|
| Hospital Emergency General | Not yet recruiting | Beijing | Beijing Municipality | 100028 | China |
|
| The First People's Hospital of Changzhou | Not yet recruiting | Changzhou | Jiangsu | 213003 | China |
|
| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215005 | China |
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| The Second People's Hospital of Wuxi | Not yet recruiting | Wuxi | Jiangsu | 214002 | China |
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| The Affiliated Hospital of Xuzhou Medical College | Not yet recruiting | Xuzhou | Jiangsu | 221006 | China |
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| The First Affiliated Hospital Of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310016 | China |
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| Jinhua Central Hospital | Not yet recruiting | Jinhua | Zhejiang | 321000 | China |
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| Lishui Central Hospital | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
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| Quzhou People's Hospital | Not yet recruiting | Quzhou | Zhejiang | 324000 | China |
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| Shaoxing People's Hospital | Not yet recruiting | Shaoxing | Zhejiang | 312000 | China |
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| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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