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

TransMedics

Status: Completed

Conditions: OCS Lung System

Treatments: Device: OCS Lung System

Study type: Observational

Funder types: Industry

Identifiers

NCT04194398

OCS-LUN-122018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registered male or female primary double lung transplant candidate
• Age ≥18 years old
• Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion criteria

• Prior solid organ or bone marrow transplant
• Single lung recipient
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Trial design

79 participants in 1 patient group

OCS Expand Trial Cohort

Description:

All patients previously enrolled in the EXPAND Lung trial.

Treatment:

Device: OCS Lung System