Freedom Inguinal Hernia Repair System Study

Stopped early · Not applicable

Conditions studied: Primary Inguinal Hernia

In brief

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.

Key facts

Study ID

NCT01984996

Run by

Insightra Medical, Inc.

People needed

100

Starts

2013-12-01

Last updated by the study team

2016-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Metabolic Clinic and Research Center — Los Angeles, California, United States
• Witham Health Services — Lebanon, Indiana, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• New Hannover Regional Medical Center — Wilmington, North Carolina, United States
• Herz Jesu Krankenhaus GmbH — Vienna, Austria
• Istituto Clinico Sant'Ambrogio — Milan, Italy
• Azienda Policlinico Umberto I — Roma, Italy
• Policlinico Tor Vergata — Roma, Italy

Full record on ClinicalTrials.gov

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