Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

This study is currently recruiting participants.
Verified March 2013 by be Medical
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01816867
First received: March 20, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Ventral Hernia
Device: Intramesh T1 implantation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry

Resource links provided by NLM:


Further study details as provided by be Medical:

Primary Outcome Measures:
  • Recurrence rate at 12 months determined by clinical examination [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraoperative complications [ Time Frame: peri-procedural ] [ Designated as safety issue: Yes ]

    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

  • Post-operative complications [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]

    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

  • Seroma [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The rate of seroma at 1 month after index-procedure.

  • Freedom from hernia-related reinterventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reinterventions at 12 months after index-procedure

  • Late complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Late complications at 12 months after index-procedure:

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


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with a ventral hernia Device: Intramesh T1 implantation
Other Name: Intramesh T1 Cousin Biotech

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a ventral hernia

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816867

Contacts
Contact: Kurt Van der Speeten, MD, PhD 089325050 kurt.vanderspeeten@zol.be
Contact: Joris Coteur, MSc

Locations
Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Kurt Van der Speeten, MD, PhD         
Sponsors and Collaborators
be Medical
Investigators
Principal Investigator: Kurt Van der Speeten, MD, PhD Ziekenhuis Oost-Limburg
  More Information

No publications provided

Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT01816867     History of Changes
Other Study ID Numbers: BM-T1-08
Study First Received: March 20, 2013
Last Updated: March 21, 2013
Health Authority: Belgium: FAGG

Keywords provided by be Medical:
hernia
Treatment
laparoscopic
open technique

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 16, 2014