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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01183325
First received: August 12, 2010
Last updated: February 1, 2013
Last verified: February 2013
History of Changes

August 12, 2010
February 1, 2013
September 2009
April 2011   (final data collection date for primary outcome measure)
Percentage of adequately placed patches [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01183325 on ClinicalTrials.gov Archive Site
  • Perioperative morbidity rate [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Pre- and postoperative pain [ Time Frame: At T 0 day, T 30 days and T 1 year ] [ Designated as safety issue: No ]
  • Number of patients needed a repositioning of the patch [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Reasons for inadequate positioning [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Number of repositioning necessary [ Time Frame: At T 0 days ] [ Designated as safety issue: No ]
  • Complication ratio [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Recurrence rate at 1 year [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Umbilical Hernias
  • Ventral Hernias
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
Experimental: 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
Intervention: Device: Proceed Ventral Patch placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
September 2013
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patient
  • Written informed consent
  • Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion Criteria:

  • Hernias larger than 3cm
  • Recurrence
  • Children
  • Emergency cases
  • Incisional hernias
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01183325
2009/291
No
University Hospital, Ghent
University Hospital, Ghent
Johnson & Johnson
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP