IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
Public ClinicalTrials.gov record NCT01166516. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01166516
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2010
- Primary completion
- Feb 29, 2016
- Completion
- Jun 30, 2017
- Last update posted
- Apr 16, 2018
2010 – 2017
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| University of Chicago | Chicago | Illinois | 60561 | — |
| SIU School of Medicine | Springfield | Illinois | 62794 | — |
| Olathe Medical Center | Olathe | Kansas | 66061 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| Michael DeBakey VA Medical Center | Houston | Texas | 77030 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| University of Washington | Seattle | Washington | 98115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01166516, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01166516 live on ClinicalTrials.gov.