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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04483102
The ClinicalTrials.gov registry entry for NCT04483102 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,852-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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