OCS Liver PROTECT Continuation Post-Approval Study

NCT ID: NCT05096741

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-24

Study Completion Date

2021-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OCS Liver

OCS Liver

Intervention Type DEVICE

Transplanted with a OCS preserved liver

Control

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCS Liver

Transplanted with a OCS preserved liver

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects transplanted in the OCS Liver PROTECT Trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California San Diego

La Jolla, California, United States

Site Status

Scripps

San Diego, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Tampa General

Tampa, Florida, United States

Site Status

Emory

Atlanta, Georgia, United States

Site Status

Johns Hopkins

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

University of Texas Southwest

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OCS-LVR-01-PAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hepatic Transplantation Registry
NCT05944042 RECRUITING