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

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.

Study Overview

• Status: Completed
• Conditions: OCS Lung System
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Hospitals Leuven
• Germany
  • Hannover, Germany, D-300625
    • Hannover Medical School
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • California
    • Los Angeles, California, United States, 90095
      • University of California at Los Angeles
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCS Expand Trial Cohort; All patients previously enrolled in the EXPAND Lung trial.	Device: OCS Lung System; Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	2 years
Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	3 years
Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	4 years
Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	5 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)	Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.	2 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)	Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.	3 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)	Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.	4 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)	Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.	5 years

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LUN-122018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes