NCT07361718

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Jun 2028

First Submitted

Initial submission to the registry

November 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

January 23, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

November 21, 2025

Last Update Submit

January 15, 2026

Conditions

Lung Transplant Surgery

Outcome Measures

Primary Outcomes (1)

  • Acceptance rate to transplant

    after the transplant

Secondary Outcomes (3)

  • 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

Study Arms (2)

OCS

EXPERIMENTAL
Device: Organ Care system

X vivo

EXPERIMENTAL
Device: ex vivo lung perfusion for eventual lung transplant

Interventions

ex vivo lung perfusion for eventual lung transplantDEVICE

ex vivo lung repefusion to evaluate lung function

X vivo
Organ Care systemDEVICE

organ care system

OCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Aoubo

Bologna, BO, 40138, Italy

Location

Central Study Contacts

Filippo FA Antonacci, MD

CONTACT

+390512145593filippo.antonacci@aosp.bo.it

Melania MM Milanese, Pharmacy

CONTACT

melania.milanese@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

January 23, 2026

Record last verified: 2025-12

Locations

IT(1)