NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study
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.
Checked against the public recordLast updated Jul 15, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- C. R. Bard
- Interventions being studied
- Other: Control; Device: ProGEL Pleural Air Leak Sealant with standard surgical closure; Device: ProGEL Pleural Air Leak Sealant without standard surgical closure
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- St. Vincent Birmingham & St. Vincent EastBirmingham, Alabama
- University of Alabama in BirminghamBirmingham, Alabama
- Jacksonville Center for ResearchJacksonville, Florida
- Moffit Cancer CenterTampa, Florida
- WellStar Research InstituteAtlanta, Georgia
- Emory UniversityAtlanta, Georgia
- Indiana UniversityIndianapolis, Indiana
- St. Vincent Hospital and Health Care CenterIndianapolis, Indiana
- Greater Baltimore Medical CenterBaltimore, Maryland
- Mass General HospitalBoston, Massachusetts
- Brigham Womens' HospitalBoston, Massachusetts
- Beth Israel Deconess Medical CenterBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2021. Always confirm current availability with the study team.