Trials / Terminated
TerminatedNCT04862156
WP02 Continued Access Study
Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- OrganOx Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Normothermic Machine Perfusion (NMP) | Storage and transportation of the donated liver using the OrganOx metra device. |
Timeline
- Start date
- 2021-10-10
- Primary completion
- 2022-07-31
- Completion
- 2023-07-07
- First posted
- 2021-04-27
- Last updated
- 2025-04-15
- Results posted
- 2023-11-29
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04862156. Inclusion in this directory is not an endorsement.