Management of BPF (Bronchopleural Fistulae)NCT01872312
Spiration IBV® Valve System and Spiration Airway Sizing Kit
A study testing treatment with valves (The Spiration® IBV Valve System) in people with Management of BPF (Bronchopleural Fistulae), run by Ohio State University at 1 site in United States.
Trial summary
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Management of BPF (Bronchopleural Fistulae)
- What is being tested?
- treatment with valves (The Spiration® IBV Valve System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2012to 14 Feb 2014
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresolved BPF
- Not candidate for surgical repair
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
Read the detailed description
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.
- Being tested
- treatment with valves (The Spiration® IBV Valve System)
- Keywords
- BPF(Bronchopleural fistulae)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with valves (The Spiration® IBV Valve System)Device
Also called spiration valve, IBV Valve System
treat BPF
| Study group | Role | What they receive |
|---|---|---|
| treatment | Other | Loading IBV® Valve System Receives: Device: treatment with valves (The Spiration® IBV Valve System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of BPF (Bronchopleural Fistulae)
expected resolution of BPF (Bronchopleural Fistulae) in three weeks
Measured: 6 weeks
resolutin of BPF
anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start25 Mar 2012
- Primary completion14 Feb 2014
- Study completion14 Feb 2014
Why it stopped: Not sure. PI is no longer at OSU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of BPF (Bronchopleural Fistulae)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Corporation of the Americas
- Responsible party
- Sponsor
- Investigators
- shaheen Islam, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872312
- Sponsor's protocol ID
- 2012H0033
- Status last verified
- Jun 2022
- First submitted
- 10 Apr 2013
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.
- ClinicalTrials.gov ID
- NCT01872312
- Acronym / sponsor ID
- 2012H0033
- Keywords
- BPF(Bronchopleural fistulae)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not sure. PI is no longer at OSU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Olympus Corporation of the Americas
- Study start
- 25 Mar 2012 (actual)
- Primary completion
- 14 Feb 2014 (actual)
- Study completion
- 14 Feb 2014 (actual)
- First posted
- 7 Jun 2013 (estimated)
- 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.
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
Detailed description
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Other | Device: treatment with valves (The Spiration® IBV Valve System)Loading IBV® Valve System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unresolved BPF
- Not candidate for surgical repair
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| treatment with valves (The Spiration® IBV Valve System)Also: spiration valve, IBV Valve Systemtreat BPF | Device | treatment |
Primary outcome
resolution of BPF (Bronchopleural Fistulae)
Time frame: 6 weeks
expected resolution of BPF (Bronchopleural Fistulae) in three weeks
resolutin of BPF
Time frame: 6 weeks
anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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.
shaheen Islam, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with valves (The Spiration® IBV Valve System) in people with Management of BPF (Bronchopleural Fistulae), run by Ohio State University at 1 site in United States.
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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
resolution of BPF (Bronchopleural Fistulae) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 30 Jun 2022.