Endobronchial Silicone Valve for Patients With Emphysema

Официальное название

Bronchoscopic Lung Volume Reduction With Endobronchial Silicone Valve for Patients With Emphysema: a Randomised Controlled Trial

Обзор

The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.

Подробное описание

The Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) is a novel designed implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The ESV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

This clinical trial included two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that the after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Вмешательства

• Устройство ESV
  This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
• Другое Optimal Medical Management (OMM)
  This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Первичные конечные точки

• Forced Expiratory Volume in 1-second (FEV1) [Срок оценки: 1-year]

Вторичные конечные точки (3)

• FEV1 Post-bronchodilator Absolute Change [Срок оценки: 1 year]
• St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: 1 year]
• 6-minute Walk Distance [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Clinical and radiological evidence of emphysema
• Nonsmoking for 4 months prior to screening interview
• BMI less than 35 kg/m2
• Stable on current medication regimen
• Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
• Residual Volume less than 175% predicted (determined by body plethysmography)
• Little or no collateral ventilation (CV-) as determined using the Chartis System

Критерии исключения

• Had two or more hospitalizations over the last year for a COPD exacerbation
• Had two or more hospitalizations over the last year for pneumonia
• Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
• Had a heart attack or congestive heart failure within the last 6 months
• Have heart arrhythmia
• Is alpha-1 antitrypsin deficient

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07097896 · 2025-ESV-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗