ClinicalTrials.gg
Enrolling by invitationNCT07578441Updated May 22, 2026

VitaSmart HOPE System: Bridge to HOPE Registry

An observational study in End Stage Liver DIsease and Liver Failure, sponsored by Bridge to Life Ltd.. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Bridge to Life Ltd. · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
5,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in End Stage Liver Disease with a site in United States — 9 open to participants now, 15 under way, none of them phase 3. End Stage Liver Disease · United States.

Planned enrollment
2nd of 18
5,000 · median 132
Started
2026
with 1 other
Observational
18 of 66
3 open now
Primary completion
2028-12
later than 11 of 14 live
Registered
66th of 66
by date
Lead sponsor
2 of 66
Bridge to Life Ltd.

Among the 66 studies in End Stage Liver Disease with a site in United States, this one is the 2nd largest by planned enrollment of the 18 observational ones that give a count, is one of 2 that started in 2026, is one of 18 observational ones, reaches primary completion later than 11 of the 14 other live ones, and was the 66th registered.

End Stage Liver Disease

154 studies on the registry are indexed under End Stage Liver Disease; 30 are open to participants now.

Browse End Stage Liver Disease studies →

Open to participants now

9 of the 66 studies in End Stage Liver Disease with a site in United States are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 21 End Stage Liver Disease studies recruiting now, 14 (67%) set no upper age limit and 6 (29%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • End Stage Liver DIsease
  • Liver Failure

Keywords

  • Liver preservation
  • VitaSmart
  • Hypothermic Oxygenated Perfusion
  • HOPE
  • Hypothermic Oxygenated Machine Perfusion
  • Liver transplantation
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Liver from a living donor
  2. Split liver transplant
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • Devicehypothermic 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.

06

What researchers measure

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)

    Time frame: 1-year post-transplant

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2026
First posted
May 11, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2033
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07578441
Lead sponsor
Bridge to Life Ltd.
Responsible party
Sponsor
First posted
May 11, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2033 (estimated)
Last update
May 22, 2026

Study contacts

David Foley, MD
study chair · University of Wisconsin, Madison
Andrea Schlegel, MD, MBA
study chair · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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