INSPIRE Continuation Post-Approval Study

• Sponsor: TransMedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03868904
• Collaborator: (none)
• Enrollment: 220
• Locations: 17
• Actual Duration (Months): 27.4
• Patients Per Site: 12.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Device: OCS Lung System

Study Design

• Study Type: Observational
• Actual Enrollment: 220 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
• Actual Study Start Date: Jun 30, 2019
• Actual Primary Completion Date: Oct 12, 2021
• Actual Study Completion Date: Oct 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
OCS Lung INSPIRE Trial	Device: OCS Lung System; No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial.

Outcome Measures

Primary Outcome Measures

1. Brochiolitis Obliterans Syndrome (BOS) -free survival [5 years post transplant]

   BOS-free survival

Secondary Outcome Measures

1. Survival [5 years]

   Survival post transplant

2. Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) [5 years]

   Freedom from BOS

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	UCLA Medical Center	Los Angeles	California	United States	90095
3	University of California at San Francisco	San Francisco	California	United States	94143
4	Indiana University	Indianapolis	Indiana	United States	46202
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	University of Minnesota	Minneapolis	Minnesota	United States	55455
7	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
8	St. Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
9	University of Leuven Hospital	Leuven		Belgium	3000
10	University of Alberta	Edmonton	Alberta	Canada	T6G 2C8
11	N.H.C Hospital Civil	Strasbourg		France	67091
12	German Heart Institute Berlin	Berlin		Germany	D-13353
13	Hannover Medical School	Hannover		Germany	D-300625
14	University of Padua	Padua		Italy	35128
15	Hospital Universitario Puerta De Hierro	Madrid		Spain	25222
16	Papworth Hospital	Cambridge		United Kingdom	CB23 3RE
17	Harefield Hospital	Middlesex		United Kingdom	UB9 6JH

Sponsors and Collaborators

• TransMedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TransMedics
• ClinicalTrials.gov Identifier: NCT03868904
• Other Study ID Numbers: OCS-LUN-03-PAS
• First Posted: Mar 11, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans

Study Results

No Results Posted as of Apr 7, 2022