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

Completed

• Conditions: OCS Lung System
• Interventions: Device: OCS Lung System

• Registration Number: NCT04194398
• Lead Sponsor: TransMedics

Brief 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.

Study Timeline

• Study Start: 2018-12-31
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCS Expand Trial Cohort	OCS Lung System	All patients previously enrolled in the EXPAND Lung trial.

Primary Outcome Measures

Name	Time	Method
Patient and graft survival	5 years	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)	5 years	Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.

Trial Locations

Locations (8)

Hospitals Leuven; 🇧🇪 Leuven, Belgium

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Hannover Medical School; 🇩🇪 Hannover, Germany