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

January 15, 2026 updated by: Filippo Antonacci, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Irccs Aoubo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age greater than 18 years
  • informed consent
  • donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification

Exclusion Criteria:

  • lung Haematoma or signsd of lung contusion
  • signs of infecton of the graft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCS
Device: Organ Care system
organ care system
Experimental: X vivo
Device: ex vivo lung perfusion for eventual lung transplant
ex vivo lung repefusion to evaluate lung function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptance rate to transplant
Time Frame: after the transplant
after the transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
days on mechanical ventilation
Time Frame: from transplant moment since the day weaning from mechanical ventilation
from transplant moment since the day weaning from mechanical ventilation
duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)
Time Frame: from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)
from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)
mortality
Time Frame: within 90 days
within 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 697/2024/Disp/AOUBo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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