VitaSmart HOPE System: Bridge to HOPE Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions.
- Who it may be relevant to
- Registry conditions: End Stage Liver DIsease, Liver Failure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post-market, Multi-center Clinical Registry to Evaluate the Safety, Effectiveness, and Real-World Utilization of the VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System (Bridge to HOPE Registry)
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Number of Recipients alive with functioning graft at 1-year post-transplant [Time frame: 1-year post-transplant]
Eligibility criteria
Inclusion criteria
1\. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System
Exclusion criteria
- Liver from a living donor
- Split liver transplant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07578441 · HOPE-2026-01