NCT03641677已完成不适用
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
Lung Bioengineering Inc.25 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年4月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 25
- 主要终点
- 12 month survival
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must meet all of the following criteria to be enrolled in the Study:
- •18 years of age or older.
- •Male or female.
- •Patient actively awaiting a single or double lung transplant.
- •Patient or patient's representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures.
- •Patient matches with and undergoes a transplant with a donor lung.
- •Patients who meet any of the following criteria will be excluded from the study:
- •Patients listed for same-side lung re-transplantation.
- •Patients listed for multiple organ transplantation including lung and any other organ.
- •Patients listed for live donor lobar lung transplant.
- •Patients positive for human immunodeficiency virus (HIV ) or Burkholderia cenocepacia infection.
- •Patient receives a standard of care (non-EVLP ) lung transplant but does not match to an EVLP subject based on the criteria for control matching.
- •Transplanted with a lung that was perfused using another EVLP technology.
- •Participating in another respiratory or cardiovascular clinical trial.
排除标准
- •Patients listed for same-side lung re-transplantation.
- •Patients listed for multiple organ transplantation including lung and any other organ.
- •Patients listed for live donor lobar lung transplant.
- •Patients positive for human immunodeficiency virus (HIV) or Burkholderia cenocepacia infection.
- •Patient receives a standard of care (non-EVLP) lung transplant but does not match to an EVLP subject based on the criteria for control matching.
- •Participating in another interventional trial
研究组 & 干预措施
EVLP
Experimental
干预措施: Centralized Lung Evaluation System (Device)
EVLP
Experimental
干预措施: Lung Transplant (Procedure)
Control
Active Comparator
干预措施: Lung Transplant (Procedure)
结局指标
主要结局
12 month survival
时间窗: 12 months
12 Month Survival or Freedom From Mortality
时间窗: 12 Months
Survival at 12 months following lung transplantation
次要结局
未报告次要终点
研究者
研究点 (25)
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