Status:
COMPLETED
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
Lead Sponsor:
Medtronic - MITG
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.
Detailed Description
Prospective, multicenter, multinational non-comparative study. Primary Endpoint: Primary hernia recurrence\* rate at 24 month follow-up. The evaluation of hernia recurrence will be performed during a...
Eligibility Criteria
Inclusion
- All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach
- Signed informed consent form by the patient or the legally authorized representative
- Intraoperative inclusion criteria :Size of the defect: ≤ 4 cm
Exclusion
- Emergency procedure
- Current participation in other trials
- History of previous hernia at the same location.
- Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
- Patient \< 18 years
- BMI \> 35
- ASA score ≥ 4
- The investigator determined that the patient will not be able to comply with the required follow-up visits
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01848184
Start Date
May 1 2013
End Date
July 1 2016
Last Update
July 20 2018
Active Locations (10)
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1
University of South Florida
Tampa, Florida, United States, 33606
2
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 78080
3
Surgicare of Missouri
Jefferson City, Missouri, United States, 65101
4
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740