NCT06655428招募中不适用
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - a Pilot Study (CSP-12123)
Morair Medtech, LLC14 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2025年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 14
- 主要终点
- Percent of procedures where the device operated as intended
研究概览
简要总结
The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety.
Participants will:
- Have up to two ETLA procedures
- Complete five clinic follow-up visits and two virtual follow-up visits.
详细描述
ETLA offers the potential to result in significant lung volume reduction of hyperinflated emphysematous regions, providing clinically meaningful improvement in pulmonary function and quality of life to a broad population of patients with severe emphysema. The REDUCE EU Pilot study will primarily evaluate the feasibility and safety of ETLA treatment in patients with severe emphysema. Secondarily, the study will evaluate the efficacy of sequential ETLA treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years old
- •Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation
- •Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value
- •Total lung capacity (TLC) ≥ 100% predicted
- •Residual volume (RV) ≥ 175% predicted
- •6 Minute Walk Distance (6MWD) ≥ 140 meters
- •Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)
- •Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air
- •Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator
- •Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing
- •Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation
- •Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure
- •Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal
- •Cognitively able to provide written informed consent and willing to comply with study requirements
- •Severe emphysematous lung subsegments eligible for ETLA treatment
排除标准
- •Body mass index (BMI) < 16 kg/m^2 or ≥ 33 kg/m^2
- •DLCO < 20% predicted
- •Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms
- •75ml or greater sputum production per day most days of the week
- •Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
- •Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
- •Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and/or polymer. Patients whose valves have been removed > 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.
- •Pulmonary hypertension
- •Alpha-1 antitrypsin deficiency
- •Uncontrolled diabetes mellitus
- •Prior heart or lung transplant
- •Myocardial infarction or stroke within the 12 months of enrollment
- •Diagnosis of heart failure
- •Heart failure requiring hospitalization, within 6 months prior to enrollment
- •History of bleeding disorders or enhanced predisposition to bleeding
- •History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours
- •Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid [ASA]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure
- •Daily systemic steroids equivalent to > 15mg prednisolone
- •Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection
- •Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration
- •Currently enrolled in another trial studying an experimental treatment
- •Any disease or condition likely to limit survival to less than one year
- •Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA
- •Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.
- •Active aspergillus infection
- •Clinically significant bronchiectasis as determined by the Investigator
- •Radiological evidence of bronchiectasis in target region(s) and/or cystic radiological bronchiectasis in any region of the lungs
- •Clinically significant pulmonary fibrosis
- •Lung nodule not proven stable unless proven to have benign pathology
- •Large bulla (defined as > 1/3 volume of a lung)
- •Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy
- •The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased
- •Active respiratory infection or recent respiratory infection with resolution < 4 weeks prior to screening or procedure
- •Recent COPD exacerbation within < 6 weeks prior to screening or procedure
结局指标
主要结局
Percent of procedures where the device operated as intended
时间窗: Through completion of the second procedure, approximately 13 weeks
Percent of procedures where the device operated as intended per the Instructions for Use (IFU)
Incidence of serious adverse events (SAE)
时间窗: 6 months
Incidence of serious adverse events (SAE) associated with the ETLA device and/or procedure as adjudicated by an independent medical monitor.
次要结局
- Incidence of adverse events(9 months)
- FEV1 change(3, 6, and 9 months)
- Incidence of serious adverse events (SAE)(9 months)
- Residual volume (RV) change(3, 6, and 9 months)
- RV/TLC change(3, 6, and 9 months)
- 6MWT change(3, 6, and 9 months)
- SGRQ-C change(3, 6, and 9 months)
研究者
研究点 (14)
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