Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01816867
First received: March 20, 2013
Last updated: May 13, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
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: May 13, 2014
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 August 26, 2014