Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Rate of DGF
研究概览
简要总结
TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.
This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage.
The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements.
The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Donor Inclusion Criteria:
- •Donor kidney suitable for preservation
- •Only one kidney per donor will be included
- •Cold ischemia time (CIT) ≤ 24 hours
- •Donor age over 18 years old
- •Donor meets one of the following:
- •Donor after brain death (DBD), standard and extended criteria
- •Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
- •Signed written informed consent
排除标准
- •Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon
- •Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
- •Living donors
- •Previous usage of a perfusion machine (PM)
- •Kidneys not considered suitable for preservations
- •Positive serology (HIV, Hepatitis B surface antigen & C)
- •Recipient Inclusion Criteria:
- •Registered primary kidney transplant candidate, male or female
- •Age ≥ 18 years old
- •Signed written informed consent
- •Recipient Exclusion Criteria:
- •Prior solid organ or bone marrow transplant
- •Multi-organ transplant
- •Active malignancy
- •Active infection
- •Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
- •Participation in another clinical trial.
- •Patient with known donor-specific HLA antibody
研究组 & 干预措施
TB1-K
TB1-K preservation arm
干预措施: TB1-K (Device)
结局指标
主要结局
Rate of DGF
时间窗: 1 week after transplant
Rate of delayed graft function (DGF), defined as need for dialysis in the first week after transplant, once hyperacute rejection, vascular and urinary tract complications are ruled out.
次要结局
未报告次要终点