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

NCT05101460 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 315

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Lung Transplant

Interventions

DEVICE

XVIVO Perfusion System (XPS™) with STEEN Solution™

XVIVO Perfusion System (XPS™) with STEEN Solution™

Sponsors & Collaborators

  • XVIVO Perfusion

    lead INDUSTRY

Principal Investigators

  • Sarah Lowe · XVIVO Perfusion

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-29
Primary Completion
2029-04-24
Completion
2029-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05101460 on ClinicalTrials.gov