NCT04194398

OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

Detailed description

The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.

Conditions

• OCS Lung System

Interventions

Type	Name	Description
DEVICE	OCS Lung System	Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

Timeline

• Start date: 2018-12-31
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-12-11
• Last updated: 2022-04-07

Locations

8 sites across 3 countries: United States, Belgium, Germany

Regulatory

• FDA-regulated device study