Freedom Inguinal Hernia Repair System Study

Insightra Medical

Status

Terminated

Conditions

Primary Inguinal Hernia

Treatments

Device: Freedom ProFlor Inguinal Hernia Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01984996

P0069

Details and patient eligibility

About

The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.

The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled to undergo routine inguinal hernia repair
Competent to give consent
Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
Defect size at operation is between 5mm and 35mm
Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
Primary hernia at the operative site
Male or female
Life expectancy of at least 12 months
At least 18 years of age

Exclusion criteria

Signs of obvious local or systemic infection
Any previous surgery on the hernia operative site
Hernia is not in the inguinal area
Hernia is not identified as indirect or direct
Femoral hernias
Known collagen disorder
Presenting with unstable angina or NYHA class of IV
Known Pregnancy
Active drug user
Recurrence of a repair by any method
Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
Immunosuppression, prednisone>15 mg/day, active chemotherapy
End stage renal disease
Abdominal ascites
Skin infection in area of surgical field
BMI >35
Peritoneum cannot be closed