Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

May 21, 2015 updated by: be Medical

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a ventral hernia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a ventral hernia
Device: Intramesh T1 implantation
Other Names:
  • Intramesh T1 Cousin Biotech

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate at 12 months determined by clinical examination
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: peri-procedural

Defined as complications occurring during index-procedure from "skin-into-skin". The following events must be reported in the case report form:

  • enterotomy (bowel injury)
  • major bleeding requiring blood transfusion or reintervention
  • complications due to anesthesia
  • minor bleeding at a trocar insertion site
peri-procedural
Post-operative complications
Time Frame: up to 30 days

Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form:

  • local numbness
  • hematoma
  • seroma
  • superficial trocar site infection
  • mesh infection
  • hernia recurrence
  • death
up to 30 days
Seroma
Time Frame: 1 month
The rate of seroma at 1 month after index-procedure.
1 month
Freedom from hernia-related reinterventions
Time Frame: 12 months
Reinterventions at 12 months after index-procedure
12 months
Late complications
Time Frame: 12 months

Late complications at 12 months after index-procedure:

  • prolonged pain more than 8 weeks
  • local numbness
  • hernia recurrence
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

be Medical

Investigators

  • Principal Investigator: Kurt Van der Speeten, MD, PhD, Ziekenhuis Oost-Limburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (ESTIMATE)

March 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM-T1-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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