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Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair

NCT01193985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-20

No results posted yet for this study

Summary

This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.

The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.

The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.

Conditions

  • Inguinal Hernia

Interventions

DEVICE

TIGR Matrix Surgical Mesh

Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Sponsors & Collaborators

  • Novus Scientific

    lead INDUSTRY

Principal Investigators

  • Stellan Björck, MD, PhD · Sahlgrenska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-04-30
Completion
2011-03-31

Countries

  • Sweden

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 NCT01193985 on ClinicalTrials.gov