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

Novus Scientific

Status

Completed

Conditions

Inguinal Hernia

Treatments

Device: TIGR Matrix Surgical Mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT01193985

NS-WK-6

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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