Observational Study on the Clinical Use of ex Vivo Lung P... | NCT06795516

Studies
Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation

NCT06795516

Sponsor

Hannover Medical School

Status

Terminated

Last Update Posted

Mar 27, 2026Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Lung Transplantation

Interventions

Not provided

Countries

Germany

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding freeze

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Mar 3, 2026Actual

Completion Date

Mar 3, 2026Actual

First Submitted Date

Jan 17, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Jan 28, 2025Actual

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

Mar 24, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival of patients 1 year after transplantation		1 year after transplantation

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of primary graft dysfunction (PGD) after transplantation		0, 24, 48, 72 hours postTx

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Min Age 18 years
Acceptance of the organ using the XPS™ ex vivo lung perfusion system is made by the center based on clinical assessment and visual inspection

Exclusion Criteria:

The usual criteria for the assessment of donors apply
The transplanting surgeon is not satisfied with the lung assessment on the XPS™ according to clinical criteria

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

Listed patients for lung transplantation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabio Ius, Prof. Dr.	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery		Hanover		30625	Germany