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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01162564
First received: July 13, 2010
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Incisional Hernia
Ventral Hernia
 Device: NG-TSM

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Ethicon, Inc.:

Enrollment: 48
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NG-TSM
Patients receiving NG-TSM to repair an abdominal incisional/ventral hernia
 Device: NG-TSM
Flexible Composite Next Generation Tissue Separating Mesh
Other Name: Ethicon Physiomesh

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162564

Locations
United States, Missouri
Capital Region Hospital
Jefferson City, Missouri, United States, 65101
Washington University School of Medicine / Dept of Surgery
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
First Health Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
New Hanover Regional Hospital
Wilmington, North Carolina, United States, 28403
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Lynn McRoy, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Lynn McRoy MD / Medical Director, Ethicon
ClinicalTrials.gov Identifier: NCT01162564     History of Changes
Other Study ID Numbers: 200-10-002
Study First Received: July 13, 2010
Last Updated: April 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 19, 2013