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

NCT06795516 | Terminated

• 1 other identifier: EVLP XPS 2023
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplantation

Keywords

Ex-vivo Perfusion

Outcome Measures

Primary Outcomes (1)

• Survival of patients 1 year after transplantation

  1 year after transplantation

Secondary Outcomes (1)

• Occurrence of primary graft dysfunction (PGD) after transplantation

  0, 24, 48, 72 hours postTx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Listed patients for lung transplantation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Hanover, 30625, Germany

Location

Study Officials

• Fabio Ius, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

DE (1)