Prolonged Air LeakHUD-PASNCT01166516
IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
A study testing Treatment with HUD IBV Valve System in people with Prolonged Air Leak, run by Olympus Corporation of the Americas at 13 sites in United States.
Trial summary
Study to collect post-market safety data for HUD IBV Valve System, 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 LVRS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prolonged Air Leak
- What is being tested?
- Treatment with HUD IBV Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2010to Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak 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
Who cannot join
- Air leak only on force exhalation or cough
- Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis
- Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient
- Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
- Subject has co-morbidities or factors that will prevent follow-up during the study period
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Lahey Clinic
Burlington, Massachusetts, 01805
University of Chicago
Chicago, Illinois, 60561
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Michael DeBakey VA Medical Center
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
Olathe Medical Center
Olathe, Kansas, 66061
Swedish Medical Center
Seattle, Washington, 98104
University of Washington
Seattle, Washington, 98115
SIU School of Medicine
Springfield, Illinois, 62794
About this study
Official title: A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak
Study to collect post-market safety data for HUD IBV Valve System, 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 LVRS. An air leak present on post-operative 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.
- Conditions
- Prolonged Air Leak
- Being tested
- Treatment with HUD IBV Valve System
- Keywords
- Prolonged air leak, lobectomy, segmentectomy, lung volume reduction surgery (LVRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with HUD IBV Valve SystemDevice
Also called IBV Valve System
Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with HUD IBV Valve System | Other | Treatment with HUD IBV Valve System in Post-Approval Study Receives: Device: Treatment with HUD IBV Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.
Measured: Day 0 to 6 weeks
Secondary outcomes (1)
Probable Benefit
Secondary study objectives are to gather probable benefit information regarding reduction in air leaks and reduction in health care utilization to support potential future premarket applications. The response of the air leak to valve treatment will be observed and recorded along with the time of observation. Probable benefit information gathered during the study will be analyzed and summarized
Measured: Day 0 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Air LeakStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas E. Wood, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166516
- Sponsor's protocol ID
- CPR-02704
- Acronym
- HUD-PAS
- Status last verified
- Apr 2018
- First submitted
- 13 Jul 2010
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak
- ClinicalTrials.gov ID
- NCT01166516
- Acronym / sponsor ID
- HUD-PAS / CPR-02704
- Conditions
- Prolonged Air Leak
- Keywords
- Prolonged air leak, lobectomy, segmentectomy, lung volume reduction surgery (LVRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 Jul 2010 (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.
Study to collect post-market safety data for HUD IBV Valve System, 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 LVRS. An air leak present on post-operative 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with HUD IBV Valve System | Other | Device: Treatment with HUD IBV Valve SystemTreatment with HUD IBV Valve System in Post-Approval Study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak 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
Key exclusion criteria (5 listed)
- Air leak only on force exhalation or cough
- Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis
- Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient
- Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
- Subject has co-morbidities or factors that will prevent follow-up during the study period
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 HUD IBV Valve SystemAlso: IBV Valve SystemTreatment involves placing one or more valves in the airways of the lung to control a prolonged air leak. | Device | Treatment with HUD IBV Valve System |
Primary outcome
Safety
Time frame: Day 0 to 6 weeks
The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.
1 secondary outcome
Probable Benefit
Time frame: Day 0 to 6 weeks
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 17 Apr 2018.
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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.
Douglas E. Wood, MD principal investigator
University of Washington
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with HUD IBV Valve System in people with Prolonged Air Leak, run by Olympus Corporation of the Americas at 13 sites 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 1 inclusion and 5 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 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?
Safety (time frame: Day 0 to 6 weeks). 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 17 Apr 2018.