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
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
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.