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RECRUITING
NCT05101460

An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant

Sponsor: XVIVO Perfusion

View on ClinicalTrials.gov

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

DEVICE

XVIVO Perfusion System (XPS™) with STEEN Solution™

XVIVO Perfusion System (XPS™) with STEEN Solution™

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States