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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07361718

Acronym

EVOLUTION

Enrollment

Registered

2026-01-23

Start date

2026-01-01

Completion date

2028-06-30

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant Surgery

Brief 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.

Interventions

DEVICEex vivo lung perfusion for eventual lung transplant

ex vivo lung repefusion to evaluate lung function

DEVICEOrgan Care system

organ care system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Acceptance rate to transplant	after the transplant

Secondary

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

Countries

Italy

Contacts

CONTACTFilippo FA Antonacci, MD

filippo.antonacci@aosp.bo.it+390512145593

CONTACTMelania MM Milanese, Pharmacy

melania.milanese@aosp.bo.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026