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Parietex Progrip Study

NCT00827944 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2016-11-17

Study results available
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Summary

The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

Conditions

  • Hernia, Inguinal

Interventions

DEVICE

Parietex Progrip

Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.

DEVICE

Low weight polypropylene mesh

Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
74 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Belgium
  • Germany
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00827944 on ClinicalTrials.gov