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

Completed

• Conditions: Incisional Hernia; Ventral Hernia
• Interventions: Device: NG-TSM

• Registration Number: NCT01162564
• Lead Sponsor: Ethicon, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-25
• Last Update Posted: 2011-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Subject must be able to provide written informed consent
• Male or female subjects that are ≥ 18 years of age
• Female subjects must be using adequate contraception, or be surgically sterile, postmenopausal or practicing abstinence, and not planning to become pregnant
• Planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result

Exclusion Criteria

• Subjects with a potential growth as NGTSM will not stretch significantly
• Female subjects who are pregnant on the day of implantation
• Surgical site (mesh implantation site) that is classified as contaminated (acute, non purulent, inflamed) or dirty/infected (containing retained devitalized tissue and those that involve existing clinical infection or perforated viscera)
• Subjects who have received investigational articles less than 30 days prior to enrollment or who are currently receiving investigational products or devices
• Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NG-TSM	NG-TSM	Patients receiving NG-TSM to repair an abdominal incisional/ventral hernia

Trial Locations

Locations (6)

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

Washington University School of Medicine / Dept of Surgery; 🇺🇸 St. Louis, Missouri, United States

Capital Region Hospital; 🇺🇸 Jefferson City, Missouri, United States

First Health Moore Regional Hospital; 🇺🇸 Pinehurst, North Carolina, United States

New Hanover Regional Hospital; 🇺🇸 Wilmington, North Carolina, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States