OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

NCT ID: NCT05096754

Last Updated: 2023-12-08

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

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-03

Study Completion Date

2023-02-02

Brief Summary

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

Detailed Description

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Conditions

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Liver Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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OCS Liver

Transplant with an OCS preserved liver.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scripps

La Jolla, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Johns Hopkins

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Mount Sinai

New York, New York, 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

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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OCS-LVR-02-PAS

Identifier Type: -

Identifier Source: org_study_id