Purpose

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Registered primary liver transplant candidate
  • Age ≥ 18 years
  • Obtained informed consent

Exclusion Criteria

  • Acute, fulminant liver failure
  • Prior solid organ or bone marrow transplant
  • Ventilator dependent on day of transplant/donor organ offer

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OCS Preserved Livers
This is a single-arm trial of OCS preserved livers used for transplantation.
  • Device: OCS Liver System
    The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

Recruiting Locations

University of Texas San Antonio
San Antonio, Texas 78249
Contact:
Jillian Woodworth
210-567-9229
woodworthj@uthscsa.edu

More Details

Status
Recruiting
Sponsor
TransMedics

Study Contact

Kelly Jork
978-494-3918
kjork@transmedics.com

Detailed Description

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.