NCT04194437

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

July 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
1 month until next milestone

Results Posted

Study results publicly available

January 17, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

December 9, 2019

Results QC Date

December 23, 2024

Last Update Submit

September 3, 2025

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

  • Liver Graft Survival Through 6 Months Post-transplant

    Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation

    6 months

Study Arms (1)

OCS Preserved Livers

EXPERIMENTAL

This is a single-arm trial of OCS preserved livers used for transplantation.

Device: OCS Liver System

Interventions

OCS Liver SystemDEVICE

The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

OCS Preserved Livers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Texas San Antonio

San Antonio, Texas, 78249, United States

Location

Related Publications (1)

  • Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.

    PMID: 33650998DERIVED

Results Point of Contact

Title
VP Cliinical Affairs
Organization
TransMedics, Inc.
ldamme@transmedics.com
978-552-0900

Study Officials

  • Ahmed Elbetanony, MD

    TransMedics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

July 24, 2020

Primary Completion

March 22, 2022

Study Completion

December 16, 2024

Last Updated

September 5, 2025

Results First Posted

January 17, 2025

Record last verified: 2025-09

Locations

US(4)