NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
Public ClinicalTrials.gov record NCT01394978. 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
AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
Study identification
- NCT ID
- NCT01394978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 444 participants
Conditions and interventions
Conditions
Interventions
- Control Other
- ProGEL Pleural Air Leak Sealant with standard surgical closure Device
- ProGEL Pleural Air Leak Sealant without standard surgical closure Device
Other · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 2011 (Type not available)
- Primary completion
- Feb 2016 (Actual)
- Completion
- Feb 2016 (Actual)
- Last update posted
- Jul 15, 2021
2011 – 2016
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Vincent Birmingham & St. Vincent East | Birmingham | Alabama | 35243 | — |
| University of Alabama in Birmingham | Birmingham | Alabama | 35894 | — |
| Jacksonville Center for Research | Jacksonville | Florida | 32207 | — |
| Moffit Cancer Center | Tampa | Florida | 33612 | — |
| WellStar Research Institute | Atlanta | Georgia | 30060 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46290 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Mass General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham Womens' Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deconess Medical Center | Boston | Massachusetts | 02215 | — |
| UMass Memorial Medical | Worcester | Massachusetts | 01605 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Dean Foundation for Health, Research and Education, Inc. | Madison | Wisconsin | 53715 | — |
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 NCT01394978, 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 Jul 15, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01394978 live on ClinicalTrials.gov.