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Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816867
First Posted: March 22, 2013
Last Update Posted: May 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
be Medical
March 20, 2013
March 22, 2013
May 22, 2015
January 2013
October 2014   (Final data collection date for primary outcome measure)
Recurrence rate at 12 months determined by clinical examination [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01816867 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Seroma [ Time Frame: 1 month ]
    The rate of seroma at 1 month after index-procedure.
  • Freedom from hernia-related reinterventions [ Time Frame: 12 months ]
    Reinterventions at 12 months after index-procedure
  • Late complications [ Time Frame: 12 months ]

    Late complications at 12 months after index-procedure:

    • prolonged pain more than 8 weeks
    • local numbness
    • hernia recurrence
Same as current
Not Provided
Not Provided
 
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
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.
Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
Patients with a ventral hernia
Ventral Hernia
Device: Intramesh T1 implantation
Other Name: Intramesh T1 Cousin Biotech
Patients with a ventral hernia
Intervention: Device: Intramesh T1 implantation
Not Provided
 
Completed
96
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01816867
BM-T1-08
No
Not Provided
Not Provided
be Medical
be Medical
Not Provided
Principal Investigator: Kurt Van der Speeten, MD, PhD Ziekenhuis Oost-Limburg
be Medical
May 2015