Freedom Inguinal Hernia Repair System Study

Primary Inguinal Hernia Clinical Trial

Official title:

Freedom Inguinal Hernia Repair System Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01984996
• Other study ID #: P0069
• Status: Terminated
• Phase: N/A
• First received: November 4, 2013
• Last updated: June 7, 2016
• Start date: December 2013

Study information

• Verified date: January 2016
• Source: Insightra Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Primary Inguinal Hernia

Intervention

Device:
• Freedom ProFlor Inguinal Hernia Implant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Insightra Medical, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study-related complications/adverse events		3 years	No
Primary	Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals	Measure quality of life for patients undergoing inguinal hernia repair.	1 week, 3, 6, 9, 12, 18, 24, and 36 months.	No
Secondary	Evaluate the 14-day pain and medication log	Patient will record pain score and medications for 14 consecutive days.	14 days	No