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NCT Number: NCT07361718

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

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Key information

Conditions

Lung Transplant Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irccs Aoubo

Bologna, BO, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ex vivo lung perfusion for eventual lung transplant

Device

ex vivo lung repefusion to evaluate lung function

Organ Care system

Device

organ care system

Primary outcomes

  1. Acceptance rate to transplant

    Time frame: after the transplant

Secondary outcomes

  1. days on mechanical ventilation

    Time frame: from transplant moment since the day weaning from mechanical ventilation

  2. duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)

    Time frame: from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)

  3. mortality

    Time frame: within 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Filippo FA Antonacci, MD

CONTACT

[email protected]

+390512145593

Melania MM Milanese, Pharmacy

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: EVOLUTION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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