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Freedom Inguinal Hernia Repair System Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984996
Recruitment Status : Terminated (Company was dissolved.)
First Posted : November 15, 2013
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Insightra Medical, Inc.

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals [ Time Frame: 1 week, 3, 6, 9, 12, 18, 24, and 36 months. ]
Measure quality of life for patients undergoing inguinal hernia repair.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Evaluate the 14-day pain and medication log [ Time Frame: 14 days ]
Patient will record pain score and medications for 14 consecutive days.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 7, 2013)
Study-related complications/adverse events [ Time Frame: 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Freedom Inguinal Hernia Repair System Study
Official Title  ICMJE Freedom Inguinal Hernia Repair System Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Inguinal Hernia
Intervention  ICMJE Device: Freedom ProFlor Inguinal Hernia Implant
Study Arms  ICMJE Experimental: Freedom ProFlor Inguinal Hernia Implant
Intervention: Device: Freedom ProFlor Inguinal Hernia Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
150
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01984996
Other Study ID Numbers  ICMJE P0069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Insightra Medical, Inc.
Study Sponsor  ICMJE Insightra Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karl LeBlanc, M.D., M.B.A., F.A.C.S. Our Lady of the Lake Regional Medical Center
PRS Account Insightra Medical, Inc.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP