NCT01162564

Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Incisional Hernia
• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	NG-TSM	Flexible Composite Next Generation Tissue Separating Mesh

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-07-14
• Last updated: 2011-04-27

Locations

6 sites across 1 country: United States