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

July 13, 2010
April 25, 2011
June 2010
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01162564 on ClinicalTrials.gov Archive Site
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Flexible Composite Next Generation Tissue Separating Mesh in Laparoscopic Incisional/Ventral Hernia Repair
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Incisional Hernia
  • Ventral Hernia
Device: NG-TSM
Flexible Composite Next Generation Tissue Separating Mesh
Other Name: Ethicon Physiomesh
NG-TSM
Patients receiving NG-TSM to repair an abdominal incisional/ventral hernia
Intervention: Device: NG-TSM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01162564
200-10-002
No
Lynn McRoy MD / Medical Director, Ethicon
Ethicon, Inc.
Not Provided
Study Director: Lynn McRoy, MD Ethicon, Inc.
Ethicon, Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP