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

NCT01183325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-12-05

No results posted yet for this study

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

  • Umbilical Hernias
  • Ventral Hernias

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Frederik Berrevoet, MD · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-04-30
Completion
2013-09-30

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183325 on ClinicalTrials.gov