Clinical Trials Directory

Trials / Completed

CompletedNCT01183325

Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues. 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.

Conditions

Interventions

TypeNameDescription
DEVICEProceed Ventral Patch placementPlacement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

Timeline

Start date
2009-09-01
Primary completion
2011-04-01
Completion
2013-09-01
First posted
2010-08-17
Last updated
2014-12-05

Locations

2 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT01183325. Inclusion in this directory is not an endorsement.