Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair - Full Text View

Purpose

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	Intervention
Inguinal Hernia	Device: TIGR Matrix Surgical Mesh

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Novus Scientific:

Primary Outcome Measures:

Frequency of Adverse Events or Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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:

Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

Enrollment:	40
Study Start Date:	April 2009
Study Completion Date:	March 2011
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intervention	Device: TIGR Matrix Surgical Mesh Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193985

Locations

Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Kungsbacka Hospital
Kungsbacka, Sweden

Sponsors and Collaborators

Novus Scientific

Investigators

Principal Investigator:

Stellan Björck, MD, PhD

Sahlgrenska University Hospital, Sweden

More Information

No publications provided

Responsible Party:	Henrik Magnusson, Novus Scientific
ClinicalTrials.gov Identifier:	NCT01193985 History of Changes
Other Study ID Numbers:	NS-WK-6
Study First Received:	September 1, 2010
Last Updated:	April 19, 2011
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 23, 2013