NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | February 2016 |
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
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.
ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term
safety over 90 days of follow-up.
Patients having open thoracotomy involving lung resection surgery will be considered for the
study. Subjects will be examined for adverse events and complications from either the
treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the
surgery.
study. Subjects will be examined for adverse events and complications from either the
treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the
surgery.
Inclusion Criteria:
- Scheduled for an open thoracotomy for lung resection
- Has at least one or more intraoperative visible air leak >= 2 mm following the lung
resection surgery
Exclusion Criteria:
- Pregnant or breast feeding
- History of an allergic reaction to Human Serum Albumin
- Has a significant clinical disease or condition
- Had previous open thoracotomy procedures
- Unable to participate in all necessary study activities due to physical or mental
limitations
We found this trial at
18
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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