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

Not Applicable

Completed

• Conditions: Inguinal Hernia

• Registration Number: NCT01193985
• Lead Sponsor: Novus Scientific

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-04
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Patients who have given informed consent
• Male, 18 years and older.
• Patients with primary unilateral inguinal hernia
• Planned surgery procedure according to Lichtenstein technique

Exclusion Criteria

• Patients who are unwilling and/or unable to give informed consent
• Hernia strangulated or irreducible
• Recurrent Hernia
• Previous mesh surgery on the same side
• Class >IIa patients
• Unable to walk 500 meters
• BMI >30 kg/m2
• Warfarin treatment, ongoing or within two weeks of surgery.
• Peripheral artery disease
• Chronic back pain, as judged by the investigator.
• Hip joint arthrosis
• Hypermobility syndrome, as judged by the investigator.
• Constipation
• Drug or alcohol abuse
• COPD (chronic obstructive pulmonary disease)
• Patients at increased risk of death from a pre-existing concurrent illness
• Patients participating in another clinical study
• Patients who have used any other investigational drug or device within 1 month
• Patients who cannot communicate reliably with the investigator
• Patients who are unlikely to cooperate with the requirements of the study
• Patients who are employees at the investigational site; relatives or spouse of the PI.
• Patients not suitable based upon investigator decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events or Serious Adverse Events	12 months	Safety is assessed by monitoring the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to the mesh and rehabilitation. AEs and SAEs will be collected during surgery and throughout the follow up period. Possible adverse reactions with the use of any prosthesis may include but are not limited to infection, inflammation, extrusion, dhesion, fistula formation, seroma formation, hematoma, and recurrence of the hernia or tissue defect.

Secondary Outcome Measures

Name	Time	Method
Pain	12 months	The experienced pain will be measured by an ungraded Visual Analogue Scale (VAS). VAS will be assessed before the surgery and during the follow up period and elucidate the pain experienced during different conditions. A symptoms questionnaire and an analgesics diary will be used to assess the performance of the WK-6 surgical mesh for use in inguinal hernia repair.

Trial Locations

Locations (2)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Kungsbacka Hospital; 🇸🇪 Kungsbacka, Sweden