WP02 Continued Access Study
NCT04862156 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-04-15
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
- Liver Transplantation
Interventions
- DEVICE
-
Normothermic Machine Perfusion (NMP)
Storage and transportation of the donated liver using the OrganOx metra device.
Sponsors & Collaborators
-
North American Science Associates Ltd.
collaborator NETWORK -
OrganOx Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-10
- Primary Completion
- 2022-07-31
- Completion
- 2023-07-07
- FDA Device
- Yes
Countries
- United States
Study Locations
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