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

NCT ID: NCT05101460

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2029-04-24

Brief 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.

Detailed Description

The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.

The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.

OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:

• Collects if hospitalized since last follow-up (yes, no), not the number of hospitalizations
• Collects acute rejection episodes (yes treated, yes not treated, no), not the number of episodes
• Collects Karnofsky Score as replacement for Physical and functional capacity
• Employment limitations has been updated to working for income (yes or no)
• No longer collects BOS, XVIVO to request BOS evaluations on subjects with visits prior to June 30, 2020 and any other omissions of end points not available in the data requested via STAR request.
• Collects FEV1 (L) effective June 30, 2020 to calculate CLAD and diagnosis of CLAD, if applicable.
• No longer provides Other, Specify text in STAR request.

Conditions

Lung Transplant

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

XVIVO Perfusion System (XPS™) with STEEN Solution™

XVIVO Perfusion System (XPS™) with STEEN Solution™

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XVIVO Perfusion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaya Tiwari, BS, CCRP

Role: STUDY_DIRECTOR

XVIVO Perfusion Inc.

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Manasa Survi

Role: CONTACT

manasa.survi@xvivogroup.com

720-298-8853

Other Identifiers

XVO-003

Identifier Type: -

Identifier Source: org_study_id