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NCT04483102 · ClinicalTrials.gov registry record · NA
RESTORE Declined Livers Study
A NA study of Surgery and Liver Diseases, sponsored by Washington University School of Medicine.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04483102: Active NA study of Surgery and Liver Diseases, sponsored by Washington University School of Medicine.
NCT04483102 is a NA study of Surgery and Liver Diseases that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 25 participants, below the 52,852-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04483102, a NA study of Surgery and Liver Diseases, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
Primary Outcome
6-month graft and patient survival as an indicator of liver function after NMP- treated liver transplantation. 6-month patient survival rate will be estimated as the number of patients who survive by 6 months post-transplantation with NMP-treated livers This is a nationally accepted outcome routinely assessed in organ transplantation programs. 6-month graft survival rate = (Number of patients with no graft failure at 6-month post transplantation)/(Total number patients who received transplanta
Conditions Studied
Interventions
- DEVICE Declined liver in Normothermic Machine Perfusion (NMP)
- PROCEDURE Standard cold preservation of liver
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT04483102 still lists
NCT04483102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 52,852-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Declined liver in Normothermic Machine Perfusion (NMP) is the first listed.
NCT04483102 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04483102 about?
NCT04483102 is a clinical study titled "RESTORE Declined Livers Study". This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will r...
What is the current status of trial NCT04483102?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-12-03. Estimated completion is 2025-12-31.
What conditions does trial NCT04483102 study?
This clinical trial studies the following conditions: Surgery, Liver Diseases, Transplant; Failure, Liver.
What interventions are being tested in trial NCT04483102?
The interventions under investigation include: Declined liver in Normothermic Machine Perfusion (NMP) (DEVICE), Standard cold preservation of liver (PROCEDURE).
Who is sponsoring clinical trial NCT04483102?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04483102 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04483102's enrollment target sits among peer trials
25 115th of 120 higher than 5 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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