NCT05526326已完成不适用
OrganOx Metra® New Enrollment Post-Approval Study
OrganOx Ltd.10 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2022年11月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 10
- 主要终点
- Adverse biliary-related events
研究概览
简要总结
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.
详细描述
The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 (in the opinion of the Investigator)
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 planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
- •Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
- •Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.
结局指标
主要结局
Adverse biliary-related events
时间窗: 12-months post-transplant
Adverse biliary-related events as measured by biliary complications
次要结局
- Graft survival(12-months post-transplant)
- Subject survival(12-months post-transplant)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT04069468Boston Scientific Corporation1,247
已完成
不适用
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory SupportNon-invasive Ventilatory SupportInfant Respiratory Distress SyndromeNCT01861795Takeda40
进行中（未招募）
不适用
OCS Heart Perfusion Post-Approval RegistryTransplantNCT05047068TransMedics350
进行中（未招募）
不适用
MDR - Biomet Cannulated ScrewsFractures, BoneFracture MultipleNCT04002518Zimmer Biomet51
已完成
不适用
A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine ClearanceMultiple MyelomaNCT02849444Celgene326