Registry for assessing donor lungs using normothermic ex vivo lung perfusion
An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
This study is collecting information from patients who receive lungs treated with a special system to see how well it works and if it affects their health and quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 315 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | XVIVO Perfusion Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05101460 on ClinicalTrials.gov |
What this trial studies
The XVIVO Registry collects clinical data from all patients who receive lungs treated with the XVIVO Perfusion System™ for transplantation. This observational study aims to evaluate the long-term performance of the device and monitor any serious adverse events related to its use. The registry also incorporates long-term safety and quality of life data from previous studies involving EVLP transplants. Data collection is aligned with the UNOS and OPTN processes, ensuring comprehensive tracking of patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this registry are all patients receiving lungs treated with the XVIVO Perfusion System™ for transplantation.
Not a fit: Patients who are not receiving EVLP lungs or those who do not meet the criteria for lung transplantation may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve the assessment and utilization of donor lungs, potentially leading to better transplant outcomes.
How similar studies have performed: Other studies utilizing similar ex vivo lung perfusion techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Manasa Survi
- Email: manasa.survi@xvivogroup.com
- Phone: 720-298-8853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.