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Organ Preservation Device

OCS Liver Preservation for Liver Transplant

N/A
Waitlist Available
Research Sponsored by TransMedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Registered primary liver transplant candidate
Age ≥ 18 years
Must not have
Prior solid organ or bone marrow transplant
Acute, fulminant liver failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new system for preserving and assessing donor livers for transplant. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults over 18 who need a liver transplant and are on the waiting list. They must understand and agree to the study's process. People with sudden severe liver failure, those needing breathing support at the time of transplant, or anyone who has had an organ or bone marrow transplant before can't join.
What is being tested?
The OCS Liver System is being tested in this trial. It's designed to keep donor livers in good condition between donation and transplantation by preserving them outside the body in a specialized machine.
What are the potential side effects?
Potential side effects may include complications related to device malfunction such as damage to the liver tissue due to inadequate preservation, but specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on the liver transplant waiting list.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a solid organ or bone marrow transplant.
Select...
I am experiencing sudden severe liver failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Liver graft survival through 6 months post-transplant
Secondary study objectives
Incidence of Early Allograft Dysfunction (EAD) or primary non-function
Incidence of ischemic biliary cholangiopathy at 6 months post-transplant
Rate of donor liver utilization after OCS liver perfusion
Other study objectives
Patient and graft survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OCS Preserved LiversExperimental Treatment1 Intervention
This is a single-arm trial of OCS preserved livers used for transplantation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCS Liver System
2020
N/A
~80

Find a Location

Who is running the clinical trial?

TransMedicsLead Sponsor
23 Previous Clinical Trials
213,465 Total Patients Enrolled
Ahmed Elbetanony, MDStudy DirectorTransMedics
3 Previous Clinical Trials
100,374 Total Patients Enrolled

Media Library

OCS Liver System (Organ Preservation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04194437 — N/A
Liver Transplant Research Study Groups: OCS Preserved Livers
Liver Transplant Clinical Trial 2023: OCS Liver System Highlights & Side Effects. Trial Name: NCT04194437 — N/A
OCS Liver System (Organ Preservation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04194437 — N/A
~2 spots leftby Dec 2025
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