NCT01193985

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novus Scientific · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	TIGR Matrix Surgical Mesh	Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-04-01
• Completion: 2011-03-01
• First posted: 2010-09-02
• Last updated: 2011-04-20

Locations

2 sites across 1 country: Sweden