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

This study has been completed.
Sponsor:
Information provided by:
Novus Scientific
ClinicalTrials.gov Identifier:
NCT01193985
First received: September 1, 2010
Last updated: April 19, 2011
Last verified: April 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014