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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1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600