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

OCS Lung System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194398
• Other study ID #: OCS-LUN-122018
• Status: Completed
• Start date: December 31, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• OCS Lung System

Intervention

Device:
• OCS Lung System
Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

Locations

Country	Name	City	State
Belgium	Hospitals Leuven	Leuven
Germany	Hannover Medical School	Hannover
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California at Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of California at San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	2 years
Primary	Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	3 years
Primary	Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	4 years
Primary	Patient and graft survival	Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.	5 years
Primary	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
Primary	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
Primary	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
Primary	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