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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIGR Matrix Surgical Mesh

Device

Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Primary outcomes

Frequency of Adverse Events or Serious Adverse Events

Time frame: 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 outcomes

Pain

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novus Scientific

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Sep 2, 2010
Registry last updated: Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed