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

NCT ID: NCT01193985

Last Updated: 2011-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

TIGR Matrix Surgical Mesh

Intervention Type: DEVICE

Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Interventions

TIGR Matrix Surgical Mesh

Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novus Scientific

INDUSTRY

Sponsor Role: lead

Responsible Party

Novus Scientific

Principal Investigators

Stellan Björck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Kungsbacka Hospital

Kungsbacka, , Sweden

Countries

Sweden

Other Identifiers

NS-WK-6

Identifier Type: -

Identifier Source: org_study_id