NCT07361718

Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation

Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.

Detailed description

Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are: Organ Care System (OCS) Transmedics, a mobile machine for use at the donor site. XPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients.

Conditions

• Lung Transplant Surgery

Interventions

Type	Name	Description
DEVICE	ex vivo lung perfusion for eventual lung transplant	ex vivo lung repefusion to evaluate lung function
DEVICE	Organ Care system	organ care system

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2028-06-30
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Italy