INSPIRE Continuation Post-Approval Study

Completed

• Conditions: Bronchiolitis Obliterans

• Registration Number: NCT03868904
• Lead Sponsor: TransMedics

Brief Summary

To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Study Start: 2019-06-30
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Status Verified: 2021-11
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brochiolitis Obliterans Syndrome (BOS) -free survival	5 years post transplant	BOS-free survival

Secondary Outcome Measures

Name	Time	Method
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)	5 years	Freedom from BOS
Survival	5 years	Survival post transplant

Trial Locations

Locations (17)

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

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

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

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

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

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

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

St. Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

University of Leuven Hospital; 🇧🇪 Leuven, Belgium

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

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