End Stage Liver DIseaseNCT07578441
VitaSmart HOPE System: Bridge to HOPE Registry
An observational study of End Stage Liver DIsease and Liver Failure, run by Bridge to Life Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Liver DIsease, Liver Failure
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (recipients) undergoing liver transplantation with a deceased donor liver graft that was perfused using the VitaSmart HOPE System.
Who may be able to join
- 1. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System
Who cannot join
- Liver from a living donor
- Split liver transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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
- Being tested
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Keywords
- Liver preservation, VitaSmart, Hypothermic Oxygenated Perfusion, HOPE, Hypothermic Oxygenated Machine Perfusion, Liver transplantation
- Medical subject headings
- End Stage Liver Disease, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditionsDevice
Observational, real-world use of the VitaSmart HOPE System with a donor liver graft under standard of care conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1-year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Bridge to Life Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Foley, MD, Study chair, University of Wisconsin, MadisonAndrea Schlegel, MD, MBA, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578441
- Sponsor's protocol ID
- HOPE-2026-01
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07578441
- Acronym / sponsor ID
- HOPE-2026-01
- Conditions
- End Stage Liver DIsease, Liver Failure
- Keywords
- Liver preservation, VitaSmart, Hypothermic Oxygenated Perfusion, HOPE, Hypothermic Oxygenated Machine Perfusion, Liver transplantation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Bridge to Life Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 conditionsRecipients who received a deceased donor liver graft that was perfused using VitaSmart hypothermic oxygenated perfusion therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (recipients) undergoing liver transplantation with a deceased donor liver graft that was perfused using the VitaSmart HOPE System.
Key inclusion criteria (1 listed)
- 1. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System
Key exclusion criteria (2 listed)
- Liver from a living donor
- Split liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditionsObservational, real-world use of the VitaSmart HOPE System with a donor liver graft under standard of care conditions. | Device | Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart |
Primary outcome
Number of Recipients alive with functioning graft at 1-year post-transplant
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Foley, MD study chair
University of Wisconsin, Madison
Andrea Schlegel, MD, MBA study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease and Liver Failure, run by Bridge to Life Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Recipients alive with functioning graft at 1-year post-transplant (time frame: 1-year post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.