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

NCT05101460 | Active Not Recruiting FDA Device

• 1 other identifier: XVO-003
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant

Keywords

Lung Transplant; Transplantation lung

Outcome Measures

Primary Outcomes (2)

• Survival at 1 year post-transplant

  Primary effectiveness endpoint

  12 months

• Primary Graft Dysfunction (PGD)

  Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours

  72 hours

Secondary Outcomes (7)

• Post-transplant survival

  2 years, 3 years, 4 years and 5 years post-transplant

• Pulmonary Function Test (FEV1)

  1 year, 2 years, 3 years, 4 years and 5 years post-transplant

• Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)

  1 year, 2 years, 3 years, 4 years and 5 years post-transplant

• Hospitalizations

  1 year, 2 years, 3 years, 4 years and 5 years post-transplant

• Acute Rejection Episodes

  1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant

Interventions

XVIVO Perfusion System (XPS™) with STEEN Solution™ DEVICE

XVIVO Perfusion System (XPS™) with STEEN Solution™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Photoelectron Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sarah Lowe

  XVIVO Perfusion

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 1, 2021
• Study Start: October 29, 2019
• Primary Completion (Estimated): April 24, 2029
• Study Completion (Estimated): April 24, 2029
• Last Updated: April 21, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)