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VitaSmart HOPE System: Bridge to HOPE Registry

NCT07578441 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • End Stage Liver DIsease
  • Liver Failure

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.

Sponsors & Collaborators

  • Bridge to Life Ltd.

    lead INDUSTRY

Principal Investigators

  • David Foley, MD · University of Wisconsin, Madison

  • Andrea Schlegel, MD, MBA · The Cleveland Clinic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-12-31
Completion
2033-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578441 on ClinicalTrials.gov