- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193985
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gothenburg, Sweden
- Sahlgrenska University Hospital
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Kungsbacka, Sweden
- Kungsbacka Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stellan Björck, MD, PhD, Sahlgrenska University Hospital, Sweden
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS-WK-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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