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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05096754
Enrollment
74
Registered
2021-10-27
Start date
2020-02-03
Completion date
2023-02-02
Last updated
2023-12-08

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 CAP.

Interventions

DEVICEOCS Liver

Transplant with an OCS preserved liver.

Sponsors

TransMedics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
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 CAP

Design outcomes

Primary

MeasureTime frameDescription
Graft Survival24 MonthsLiver Graft Survival at 24 months post-transplant.

Countries

United States

Outcome results

None listed

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