NCT07068438招募中不适用
A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD
Suzhou Hengruihongyuan Medical Technology Co. LTD25 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 25
- 主要终点
- COPD Assessment Test (CAT) Score
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Patient has an SGRQ score ≥
- •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.
- •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.
排除标准
- •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).
- •Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
- •Patient is pregnant, nursing, or planning to get pregnant during study duration.
- •Patient is currently participating in another clinical study involving an investigational product.
- •Patient is receiving anticoagulation for a cardiovascular indication and, in the Primary investigator's opinion, unable to suspend anticoagulant medications (i.e., aspirin, clopidogrel, warfarin) during bronchoscopy in accordance.
- •Patient has known airway colonization with drug-resistant bacteria such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderia cepacia complex, Mycobacterium tuberculosis, Mycobacterium abscessus, Trichoderma, or other significant fungi.
研究组 & 干预措施
Pulsed Electric Field Ablation System
Experimental
干预措施: Pulse electric field ablation system (Device)
Sham Procedure
Sham Comparator
干预措施: Sham Procedure (Device)
结局指标
主要结局
COPD Assessment Test (CAT) Score
时间窗: 6 months
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
次要结局
- Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores(3, 6 and 12 months)
- 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)
- COPD Exacerbations(12 months)
- Pulmonary Function (FEV1)(3, 6 and 12 months)
- Pulmonary Function (FEV1 /FVC ratio)(3, 6 and 12 months)
- The six minute walking test (6MWT)(6 and 12 months)
- Technical success rate(Approximately 15-minutes after device removal)
研究者
研究点 (25)
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