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OCS Liver PROTECT Continuation Post-Approval Study

OCS Liver PROTECT Continuation Post-Approval Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05096741
Enrollment
300
Registered
2021-10-27
Start date
2016-01-24
Completion date
2021-11-05
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Brief summary

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

Detailed description

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

Interventions

DEVICEOCS Liver

Transplanted with a OCS preserved liver

Sponsors

TransMedics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects transplanted in the OCS Liver PROTECT Trial

Design outcomes

Primary

MeasureTime frameDescription
Liver Graft Survival2 yearsLiver Graft Survival through 2 years (24 months) after transplantation.

Other

MeasureTime frameDescription
Patient Survival2 yearsPatient Survival (freedom from mortality) through 2 years (24 months) after transplantation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026