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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162564
• Other study ID #: 200-10-002
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: April 25, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Device:
• NG-TSM
Flexible Composite Next Generation Tissue Separating Mesh

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Capital Region Hospital	Jefferson City	Missouri
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	First Health Moore Regional Hospital	Pinehurst	North Carolina
United States	Washington University School of Medicine / Dept of Surgery	St. Louis	Missouri
United States	New Hanover Regional Hospital	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States,