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

NCT01162564 | Completed

• 1 other identifier: 200-10-002
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 6

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.

Conditions

Incisional Hernia; Ventral Hernia

Study Arms (1)

NG-TSM

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

Device: NG-TSM

Interventions

NG-TSM DEVICE

Flexible Composite Next Generation Tissue Separating Mesh

Also known as: Ethicon Physiomesh

NG-TSM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for 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 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (6)

Capital Region Hospital

Jefferson City, Missouri, 65101, United States

Location

Washington University School of Medicine / Dept of Surgery

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

First Health Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

New Hanover Regional Hospital

Wilmington, North Carolina, 28403, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Incisional Hernia; Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Hernia, Abdominal

Study Officials

• Lynn McRoy, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 27, 2011

Record last verified: 2011-04

Locations

US (6)