Status:
COMPLETED
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Lead Sponsor:
Novus Scientific
Conditions:
Inguinal Hernia
Eligibility:
MALE
18+ years
Phase:
NA
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 det...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01193985
Start Date
April 1 2009
End Date
March 1 2011
Last Update
April 20 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sahlgrenska University Hospital
Gothenburg, Sweden
2
Kungsbacka Hospital
Kungsbacka, Sweden