Clinical trial NCT01984996: Freedom Inguinal Hernia Repair System Study
Official title: Freedom Inguinal Hernia Repair System Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Inguinal Hernia
Lead sponsor: Insightra Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
timeFrame: 1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Secondary outcomes:
measure: Evaluate the 14-day pain and medication log
timeFrame: 14 days
Other outcomes:
measure: Study-related complications/adverse events
timeFrame: 3 years
Locations:
city: Los Angeles
country: United States
facility: Metabolic Clinic and Research Center
state: California
city: Lebanon
country: United States
facility: Witham Health Services
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Wilmington
country: United States
facility: New Hannover Regional Medical Center
state: North Carolina
city: Wien
country: Austria
facility: Herz Jesu Krankenhaus GmbH
city: Milano
country: Italy
facility: Istituto Clinico Sant'Ambrogio
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Tor Vergata
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Karl LeBlanc, M.D., M.B.A., F.A.C.S.
role: PRINCIPAL_INVESTIGATOR
References: