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

Completed

Conditions studied: Incisional Hernia, Ventral Hernia

In brief

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.

Key facts

Study ID

NCT01162564

Run by

Ethicon, Inc.

People needed

48

Starts

2010-06-01

Expected to finish

2011-01-01

Last updated by the study team

2011-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• New Hanover Regional Hospital — Wilmington, North Carolina, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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