Trials / Completed
CompletedNCT02522871
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Detailed description
The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS™ Liver System | |
| OTHER | Control |
Timeline
- Start date
- 2016-01-24
- Primary completion
- 2019-10-22
- Completion
- 2021-11-05
- First posted
- 2015-08-13
- Last updated
- 2023-06-29
- Results posted
- 2023-06-29
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02522871. Inclusion in this directory is not an endorsement.