Trials / Recruiting
RecruitingNCT05940857
US National OCS Liver Perfusion (OLP) Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100,000 (estimated)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight. TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Liver | The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system. |
Timeline
- Start date
- 2021-10-14
- Primary completion
- 2031-10-01
- Completion
- 2031-10-01
- First posted
- 2023-07-11
- Last updated
- 2024-08-16
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05940857. Inclusion in this directory is not an endorsement.