Comparison Between Two Medical Devices for the Reconditio... | NCT07361718

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

NCT07361718

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Not yet recruiting

Last Update Posted

Jan 23, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Lung Transplant Surgery

Interventions

ex vivo lung perfusion for eventual lung transplant
Organ Care system

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2026Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Nov 21, 2025

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 23, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Filippo Antonacci, MD, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCS	Experimental		Device: Organ Care system
X vivo	Experimental		Device: ex vivo lung perfusion for eventual lung transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ex vivo lung perfusion for eventual lung transplant	Device	ex vivo lung repefusion to evaluate lung function	X vivo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptance rate to transplant		after the transplant

Secondary Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Filippo FA Antonacci, MD	Contact	+390512145593		filippo.antonacci@aosp.bo.it
Melania MM Milanese, Pharmacy	Contact			melania.milanese@aosp.bo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irccs Aoubo		Bologna	BO	40138	Italy