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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193985
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : April 20, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Device: TIGR Matrix Surgical Mesh Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Device: TIGR Matrix Surgical Mesh
Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01193985

Sahlgrenska University Hospital
Gothenburg, Sweden
Kungsbacka Hospital
Kungsbacka, Sweden
Sponsors and Collaborators
Novus Scientific
Principal Investigator: Stellan Björck, MD, PhD Sahlgrenska University Hospital, Sweden

Responsible Party: Henrik Magnusson, Novus Scientific Identifier: NCT01193985     History of Changes
Other Study ID Numbers: NS-WK-6
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal