Bronchiolitis ObliteransNCT03868904
INSPIRE Continuation Post-Approval Study
An observational study of Bronchiolitis Obliterans, run by TransMedics at 17 sites in 9 countries.
Trial summary
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- OCS Lung System
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 17 sitesin 9 countries
- Study dates
- 30 Jun 2019to 12 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who participated in TransMedics OCS Lung System INSPIRE Trial
Who may be able to join
- Participant in TransMedics OCS Lung System INSPIRE trial
Who cannot join
- None
Trial locations and contacts
17 sites in 9 countries.
17 sites in 9 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Indiana University
Indianapolis, Indiana, 46202
UCLA Medical Center
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California at San Francisco
San Francisco, California, 94143
Germany2 sites
German Heart Institute Berlin
Berlin, D-13353
Hannover Medical School
Hanover, D-300625
United Kingdom2 sites
Papworth Hospital
Cambridge, CB23 3RE
Harefield Hospital
Middlesex, UB9 6JH
About this study
Official title: OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- OCS Lung System
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Lung SystemDevice
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 group | Role | What they receive |
|---|---|---|
| OCS Lung INSPIRE Trial | Not described Receives: Device: OCS Lung System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brochiolitis Obliterans Syndrome (BOS) -free survival
BOS-free survival
Measured: 5 years post transplant
Secondary outcomes (2)
Survival
Survival post transplant
Measured: 5 years
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
Freedom from BOS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start30 Jun 2019
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868904
- Sponsor's protocol ID
- OCS-LUN-03-PAS
- Status last verified
- Nov 2021
- First submitted
- 7 Mar 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
- ClinicalTrials.gov ID
- NCT03868904
- Acronym / sponsor ID
- OCS-LUN-03-PAS
- Conditions
- Bronchiolitis Obliterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Lung INSPIRE Trial | – | Device: OCS Lung System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who participated in TransMedics OCS Lung System INSPIRE Trial
Key inclusion criteria (1 listed)
- Participant in TransMedics OCS Lung System INSPIRE trial
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCS Lung SystemNo 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. | Device | OCS Lung INSPIRE Trial |
Primary outcome
Brochiolitis Obliterans Syndrome (BOS) -free survival
Time frame: 5 years post transplant
BOS-free survival
2 secondary outcomes
Survival
Time frame: 5 years
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterans, run by TransMedics at 17 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, United Kingdom, Australia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brochiolitis Obliterans Syndrome (BOS) -free survival (time frame: 5 years post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.