RecruitingNCT05101460

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


Sponsor

XVIVO Perfusion

Enrollment

315 participants

Start Date

Oct 29, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.

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Interventions

DEVICEXVIVO Perfusion System (XPS™) with STEEN Solution™

XVIVO Perfusion System (XPS™) with STEEN Solution™


Locations(1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT05101460


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