VitaSmart HOPE System: Bridge to HOPE Registry

NCT07578441 | Enrolling By Invitation FDA Device

• 1 other identifier: HOPE-2026-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver preservation; VitaSmart; Hypothermic Oxygenated Perfusion; HOPE; Hypothermic Oxygenated Machine Perfusion; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Recipients alive with functioning graft at 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)

  1-year post-transplant

Study Arms (1)

Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart

Recipients who received a deceased donor liver graft that was perfused using VitaSmart hypothermic oxygenated perfusion therapy.

Device: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions

Interventions

hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions DEVICE

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

Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (recipients) undergoing liver transplantation with a deceased donor liver graft that was perfused using the VitaSmart HOPE System.

You may qualify if:

• \. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System

You may not qualify if:

• Liver from a living donor
• Split liver transplant

Sponsors & Collaborators

• Bridge to Life Ltd.: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• David Foley, MD

  University of Wisconsin, Madison

  STUDY CHAIR

• Andrea Schlegel, MD, MBA

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)