NCT01816867CompletedNot Applicable
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry
be Medical1 site in 1 country96 target enrollmentStarted: January 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Recurrence rate at 12 months determined by clinical examination
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is older than 18 years
- •Written informed consent is obtained from patient
- •Patient with a primary or incisional ventral hernia
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Recurrence rate at 12 months determined by clinical examination
Time Frame: 12 months
Secondary Outcomes
- Seroma(1 month)
- Freedom from hernia-related reinterventions(12 months)
- Late complications(12 months)
- Intraoperative complications(peri-procedural)
- Post-operative complications(up to 30 days)
Investigators
Study Sites (1)
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