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

NCT01193985 | Completed

• 1 other identifier: NS-WK-6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Pain

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Device: TIGR Matrix Surgical Mesh

Interventions

TIGR Matrix Surgical Mesh DEVICE

Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given informed consent
• Male, 18 years and older.
• Patients with primary unilateral inguinal hernia
• Planned surgery procedure according to Lichtenstein technique

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novus Scientific: lead

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Kungsbacka Hospital

Kungsbacka, Sweden

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stellan Björck, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

SE (2)