Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
NCT ID: NCT01183325
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2009-09-30
2013-09-30
Brief Summary
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About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).
With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.
The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Interventions
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Proceed Ventral Patch placement
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Umbilical, primary ventral hernias smaller than 3cm diameter
Exclusion Criteria
* Recurrence
* Children
* Emergency cases
* Incisional hernias
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Frederik Berrevoet, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Imelda Hospital
Bonheiden, , Belgium
University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website of University Hospital Ghent
Other Identifiers
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2009/291
Identifier Type: -
Identifier Source: org_study_id