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)
| Registry | NCT07578441 |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 5000 (Estimated) |
| Sponsor | Bridge to Life Ltd. (Industry) |
| Conditions | End Stage Liver DIsease, Liver Failure |
| Interventions | hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2028-12-01 (estimated), completion 2033-12-01 (estimated), first posted 2026-05-11, last updated 2026-05-22 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for End Stage Liver DIsease All trials for Liver Failure All trials of hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart | Device: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions | Recipients who received a deceased donor liver graft that was perfused using VitaSmart hypothermic oxygenated perfusion therapy. |
Sex: All
Inclusion Criteria: 1\. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System Exclusion Criteria: 1. Liver from a living donor 2. Split liver transplant
| Facility | City | Country | Status |
|---|---|---|---|
| Cleveland Clinic | Cleveland, Ohio | United States |