This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and handling characteristics.
The objectives of the study are to evaluate the ease of use of NG-TSM intra-operatively in laparoscopic incisional/ventral hernia repair, and assessing early outcomes post-operatively following mesh implantation, including seroma formation, hematoma, wound complications, infections, early recurrences, adverse events, and subject comfort, as well as health economic data to include quality of life, subject satisfaction data, time of procedure, length of stay, re-hospitalization, and extended hospitalization.
Study Type
OBSERVATIONAL
Enrollment
48
Flexible Composite Next Generation Tissue Separating Mesh
Capital Region Hospital
Jefferson City, Missouri, United States
Washington University School of Medicine / Dept of Surgery
St Louis, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
First Health Moore Regional Hospital
Pinehurst, North Carolina, United States
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New Hanover Regional Hospital
Wilmington, North Carolina, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States