VitaSmart HOPE System: Bridge to HOPE Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions: Observational, real-world use of the VitaSmart HOPE System with a donor liver graft under standard of care conditions.

Study summary

This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions. Clinical data from up to 5000 transplant recipients will be included in the registry at up to 20 U.S. transplant centers. This registry will include clinical data collected retrospectively from medical records of recipients already transplanted before the initiation of the registry and any new recipients of livers that meet donor selection criteria. This registry introduces no contact with the transplant recipient and registry participants will follow standard of care. Data will be collected through up to 5 years of standard of care clinical follow-up.

This registry represents minimal risk to the transplant recipients being studied. The participants included in this registry will have undergone transplant surgery with a deceased donor liver graft that was perfused using the VitaSmart HOPE System, a medical device that is cleared by the Food and Drug Administration (FDA) for commercial use in the U.S. All perfusions of deceased donor liver grafts will be performed in accordance with standard medical practice.

The objectives of this registry is to Evaluate the safety and efficacy of HOPE prior to liver transplantation in real-world clinical settings.

Eligibility

Primary outcome measure(s)

• Number of Recipients alive with functioning graft at 1-year post-transplant — 1-year post-transplant
  Number of Recipients alive with functioning graft at 1-year post-transplant (absence of graft failure or death for liver related reasons)

Trial sites (1)

Other trials for the same condition