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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with HUD IBV Valve System | Other | Treatment with HUD IBV Valve System in Post-Approval Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with HUD IBV Valve System | Device | Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas E. Wood, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States | ||
| University of Chicago |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 18, 2019 | |
| Reset | May 7, 2019 |
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|
| Day 0 to 6 weeks |
| Chicago |
| Illinois |
| 60561 |
| United States |
| SIU School of Medicine | Springfield | Illinois | 62794 | United States |
| Olathe Medical Center | Olathe | Kansas | 66061 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| Michael DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| University of Washington | Seattle | Washington | 98115 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 18, 2019 | May 7, 2019 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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