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

NCT07068438 | Recruiting

• 1 other identifier: COPD 1.0
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 13

Brief Summary

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).

Conditions

Chronic Bronchitis; COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• COPD Assessment Test (CAT) score

  3 and 12 months

• COPD Assessment Test (CAT) Score (items 1 and 2)

  3, 6 and 12 months

• St. George Respiratory Questionnaire (SGRQ-C)

  6 and 12 months

• Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores

  3, 6 and 12 months

• COPD Exacerbations

  12 months

Study Arms (2)

Pulsed Electric Field Ablation System

EXPERIMENTAL

Device: Pulse electric field ablation system

Sham Procedure

SHAM COMPARATOR

Device: Sham Procedure

Interventions

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.

Pulsed Electric Field Ablation System

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).

Sham Procedure

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• Patient has a steroid-dependent condition requiring \>10 mg of oral corticosteroid per day.
• Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
• Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, or sinus bradycardia with a heart rate of under than 45 beats per minute, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
• Subject has lung cancer.
• Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
• Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan as determined by the CT Core Lab.
• Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
• Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
• Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 2 months.
• Patient is unable to walk over 225 meters in 6 minutes.
• Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
• Patient has uncontrolled GERD.
• Patient has known severe pulmonary hypertension (pulmonary artery SP ≥ 50 mmHg).

Sponsors & Collaborators

• Suzhou Hengruihongyuan Medical Technology Co. LTD: lead

Study Sites (13)

Anhui Chest Hospital

Hefei, Anui, 230022, China

NOT YET RECRUITING

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Beijing, Beijing Municipality, 100020, China

NOT YET RECRUITING

Hospital Emergency General

Beijing, Beijing Municipality, 100028, China

NOT YET RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

NOT YET RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215005, China

NOT YET RECRUITING

The Second People's Hospital of Wuxi

Wuxi, Jiangsu, 214002, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, 221006, China

NOT YET RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China

NOT YET RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

NOT YET RECRUITING

Quzhou People's Hospital

Quzhou, Zhejiang, 324000, China

NOT YET RECRUITING

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Enguo Chen

CONTACT

+86 13588706779; cheneg@srrsh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

CN (13)