NCT01963780

International EXPAND Lung Pivotal Trial

International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Detailed description

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics: * Donor PaO2/FiO2 ≤ 300 mmHg; or * Expected ischemic time \> 6 hours; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥55 years old

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DEVICE	OCS Lung Preservation

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-11-22
• Completion: 2018-04-01
• First posted: 2013-10-16
• Last updated: 2022-07-07
• Results posted: 2022-07-07

Locations

11 sites across 4 countries: United States, Belgium, Germany, Spain