Status:
COMPLETED
Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
Lead Sponsor:
Ethicon, Inc.
Conditions:
Incisional Hernia
Ventral Hernia
Eligibility:
All Genders
18+ years
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-opera...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01162564
Start Date
June 1 2010
End Date
January 1 2011
Last Update
April 27 2011
Active Locations (6)
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1
Capital Region Hospital
Jefferson City, Missouri, United States, 65101
2
Washington University School of Medicine / Dept of Surgery
St Louis, Missouri, United States, 63110
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
First Health Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374