REACH (Research to Assess SVS Safety and Effectiveness for the Treatment of Severe EmphysemA in China) SVS Control Patient Cross-Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Forced expiratory volume at 1 second
研究概览
简要总结
This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was enrolled in the REACH SVS Study control group and has completed their participation in the Study including the 12 month follow-up visit.
- •Patient has received standard-of-care medical management and it has been stable for 6 weeks.
- •Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.
排除标准
- •Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
- •Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study.
- •Patient has demonstrated unwillingness or inability to complete baseline data collection procedures.
- •Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study.
- •Patient is unable to provide informed consent.
- •Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
- •Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the prior 3 months.
- •Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period
- •Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
研究组 & 干预措施
Treatment
The treatment algorithm is complete occlusion of one lobe of the lung by using valves to occlude all segments of the lobe. The lobe will be selected based on imaging with high resolution computed tomography (HRCT). The lobe to be treated will have severe heterogeneous emphysema based on visual exam. The selected lobe will also have an intact fissure separation with the ipsilateral lobe. An intact fissure will be estimated visually to be ≥ 90% complete after viewing the HRCT in 3 dimensions. If more than one lobe meets criteria, the investigator will determine a primary lobe to treat based on fissure completeness, heterogeneity, disease severity, and the anatomy of the airways that will be treated.
干预措施: Spiration Valve System (Device)
结局指标
主要结局
Forced expiratory volume at 1 second
时间窗: Three months
次要结局
未报告次要终点