A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch

Completed

Conditions studied: Hernia

In brief

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.

Key facts

Study ID

NCT01848184

Run by

Medtronic - MITG

People needed

126

Starts

2013-05-01

Expected to finish

2016-07-01

Last updated by the study team

2018-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Florida — Tampa, Florida, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Surgicare of Missouri — Jefferson City, Missouri, United States
• Monmouth Medical Center — Long Branch, New Jersey, United States
• Hernia Centers of Excellence — Yorktown, Virginia, United States
• General Surgery - Imelda Hospital — Bonheiden, Belgium
• Department of Surgery, Algemene Heelkunde AZ Maria Middelares Ghent — Ghent, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Department of Surgery K, Bispebjerg Hospital, University of Copenhagen — Copenhagen, Denmark
• Dr. ERIC KULLMAN — Linköping, Östergötland County, Sweden

Full record on ClinicalTrials.gov

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