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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01162564
Other study ID # 200-10-002
Secondary ID
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


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, 

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