Liver TransplantationPhase 1NCT00879268
Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
A Phase 1 study testing Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System in people with Liver Transplantation and Organ Preservation, run by Polyak, Maximilian.
Trial summary
This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Organ Preservation
- What is being tested?
- Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary/ Solitary Liver Transplant
- Lab MELD<35
- Donor age <65
Who cannot join
- Donor Liver > 30% Macrosteatosis
- DCD donor liver
- Multi-organ Recipient
- Recipient in ICU
- Retransplant
About this study
Official title: Phase 1 Study of Liver Machine Preservation With Vasosol Solution
This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.
- Conditions
- Liver Transplantation, Organ Preservation
- Being tested
- Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
- Keywords
- Liver Transplantation, Organ Preservation, Liver Preservation, Machine Perfusion, Vasosol, Machine Preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasosol Organ Perfusion Solution and Medtronic Portable Bypass SystemDevice
Also called Vasosol Solution, Medtronic Portable Bypass System
Utilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startJul 2004
- Primary completionFeb 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyak, Maximilian
- Collaborators
- Health Resources and Services Administration (HRSA)
- Investigators
- James V. Guarrera, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879268
- Sponsor's protocol ID
- G030132
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 9 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Liver Machine Preservation With Vasosol Solution
- ClinicalTrials.gov ID
- NCT00879268
- Acronym / sponsor ID
- G030132
- Conditions
- Liver Transplantation, Organ Preservation
- Keywords
- Liver Transplantation, Organ Preservation, Liver Preservation, Machine Perfusion, Vasosol, Machine Preservation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Polyak, Maximilian
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Jul 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Apr 2009 (estimated)
- 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 pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary/ Solitary Liver Transplant
- Lab MELD<35
- Donor age <65
Key exclusion criteria (5 listed)
- Donor Liver > 30% Macrosteatosis
- DCD donor liver
- Multi-organ Recipient
- Recipient in ICU
- Retransplant
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 |
|---|---|---|
| Vasosol Organ Perfusion Solution and Medtronic Portable Bypass SystemAlso: Vasosol Solution, Medtronic Portable Bypass SystemUtilization of Vasosol with Medtronic System for Machine Preservation of the Liver for Liver Transplantation | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2009.
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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. This study is not recruiting at the moment.
James V. Guarrera, M.D. principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System in people with Liver Transplantation and Organ Preservation, run by Polyak, Maximilian.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 9 Apr 2009.