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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
TIGR Matrix Surgical Mesh
Sponsored by
Novus Scientific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Sahlgrenska University Hospital
  • Kungsbacka Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Frequency of Adverse Events or Serious Adverse Events
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
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.

Full Information

First Posted
September 1, 2010
Last Updated
April 19, 2011
Sponsor
Novus Scientific
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1. Study Identification

Unique Protocol Identification Number
NCT01193985
Brief Title
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Official Title
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novus Scientific

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TIGR Matrix Surgical Mesh
Intervention Description
Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh
Primary Outcome Measure Information:
Title
Frequency of Adverse Events or Serious Adverse Events
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stellan Björck, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Kungsbacka Hospital
City
Kungsbacka
Country
Sweden

12. IPD Sharing Statement

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

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