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An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Sponsor: XVIVO Perfusion
Summary
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
315
Start Date
2019-10-29
Completion Date
2029-04-24
Last Updated
2023-07-14
Healthy Volunteers
No
Conditions
Interventions
XVIVO Perfusion System (XPS™) with STEEN Solution™
XVIVO Perfusion System (XPS™) with STEEN Solution™
Locations (1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States