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

Tracking Information

First Received Date ^ICMJE

July 13, 2010

Last Updated Date

April 25, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01162564 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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-operatively, its ease of use and handling characteristics.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Incisional Hernia
Ventral Hernia

Intervention ^ICMJE

Device: NG-TSM

Flexible Composite Next Generation Tissue Separating Mesh

Other Name: Ethicon Physiomesh

Study Group/Cohort (s)

NG-TSM

Patients receiving NG-TSM to repair an abdominal incisional/ventral hernia

Intervention: Device: NG-TSM

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01162564

Other Study ID Numbers ^ICMJE

200-10-002

Has Data Monitoring Committee

Responsible Party

Lynn McRoy MD / Medical Director, Ethicon

Study Sponsor ^ICMJE

Ethicon, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lynn McRoy, MD

Ethicon, Inc.

Information Provided By

Ethicon, Inc.

Verification Date

April 2011

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

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