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

Официальное название

A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD

Обзор

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).

Вмешательства

• Устройство Pulse electric field ablation system
  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.
• Устройство Sham Procedure
  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).

Первичные конечные точки

• COPD Assessment Test (CAT) Score [Срок оценки: 6 months]

Вторичные конечные точки (9)

• COPD Assessment Test (CAT) score [Срок оценки: 3 and 12 months]
• COPD Assessment Test (CAT) Score (items 1 and 2) [Срок оценки: 3, 6 and 12 months]
• St. George Respiratory Questionnaire (SGRQ-C) [Срок оценки: 6 and 12 months]
• Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores [Срок оценки: 3, 6 and 12 months]
• COPD Exacerbations [Срок оценки: 12 months]
• Pulmonary Function (FEV1) [Срок оценки: 3, 6 and 12 months]
• Pulmonary Function (FEV1 /FVC ratio) [Срок оценки: 3, 6 and 12 months]
• The six minute walking test (6MWT) [Срок оценки: 6 and 12 months]
• Technical success rate [Срок оценки: Approximately 15-minutes after device removal]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 13 центров

• Anhui Chest Hospital — Хэфэй
• Affiliated Beijing Chaoyang Hospital of Capital Medical University — Пекин
• Hospital Emergency General — Пекин
• The First People's Hospital of Changzhou — Changzhou
• The Second Affiliated Hospital of Soochow University — Сучжоу
• The Second People's Hospital of Wuxi — Wuxi
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou
• The First Affiliated Hospital Of Nanchang University — Nanchang
• … и ещё 5 центров

Идентификаторы

NCT: NCT07068438 · COPD 1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗