Status:

COMPLETED

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

Lead Sponsor:

be Medical

Conditions:

Ventral Hernia

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.

Eligibility Criteria

Inclusion

  • Patient is older than 18 years
  • Written informed consent is obtained from patient
  • Patient with a primary or incisional ventral hernia

Exclusion

  • Patient with a recurrent ventral hernia
  • Patient with ASA class 5 and 6
  • Patient underwent emergency surgery
  • Patient is pregnant
  • Patient with a known allergy to components of the ePTFE prosthesis
  • Patient has a life expectancy less than 1 year
  • Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors

Key Trial Info

Start Date :

January 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2014

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT01816867

Start Date

January 1 2013

End Date

October 1 2014

Last Update

May 22 2015

Active Locations (1)

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium, 3600