NCT04862156终止不适用
Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
OrganOx Ltd.14 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 14
- 主要终点
- Incidence of Early Allograft Dysfunction (EAD)
研究概览
简要总结
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or greater
- •Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
- •Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- •Subject is able and willing to comply with all study requirements
排除标准
- •Subject requiring all of the following at the time of transplantation:
- •Oxygen therapy via a ventilator/respirator
- •Inotropic support
- •Renal replacement therapy
- •Subject has acute/fulminant liver failure (UNOS status 1A)
- •Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
- •Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- •Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
结局指标
主要结局
Incidence of Early Allograft Dysfunction (EAD)
时间窗: 7 days
Severity of immediate graft injury as measured by early allograft dysfunction (EAD).
次要结局
未报告次要终点
研究者
研究点 (14)
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