Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

BE Medical

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Intramesh T1 implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT01816867

BM-T1-08

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

96 participants in 1 patient group

Patients with a ventral hernia

Treatment:

Device: Intramesh T1 implantation