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

Inguinal Hernia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01193985
Study type Interventional
Source Novus Scientific
Contact
Status Completed
Phase N/A
Start date April 2009
Completion date March 2011
View Details
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