INSPIRE Continuation Post-Approval Study

OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03868904

Enrollment

220

Registered

2019-03-11

Start date

2019-06-30

Completion date

2021-10-12

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans

Brief summary

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

Interventions

DEVICEOCS 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Brochiolitis Obliterans Syndrome (BOS) -free survival	5 years post transplant	BOS-free survival

Secondary

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

Countries

Australia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026