Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2010 |
| End Date: | March 2011 |
Single-Arm, Prospective, Multi-Center Observational Study of a Flexible Composite Next Generation Tissue Separating Mesh(NG-TSM)to Assess Ease of Use and Early Outcomes in Laparoscopic Incisional/Ventral Hernia
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.
We found this trial at
6
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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