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Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

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ClinicalTrials.gov Identifier: NCT01816867
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Ventral Hernia Device: Intramesh T1 implantation

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 96 participants
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
Study Start Date : January 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patients with a ventral hernia Device: Intramesh T1 implantation
Other Name: Intramesh T1 Cousin Biotech


Outcome Measures

Primary Outcome Measures :
  1. Recurrence rate at 12 months determined by clinical examination [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Seroma [ Time Frame: 1 month ]
    The rate of seroma at 1 month after index-procedure.

  4. Freedom from hernia-related reinterventions [ Time Frame: 12 months ]
    Reinterventions at 12 months after index-procedure

  5. Late complications [ Time Frame: 12 months ]

    Late complications at 12 months after index-procedure:

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT01816867     History of Changes
Other Study ID Numbers: BM-T1-08
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by be Medical:
hernia
Treatment
laparoscopic
open technique

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