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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.

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.


Condition or disease Intervention/treatment Phase
Primary Inguinal Hernia Device: Freedom ProFlor Inguinal Hernia Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Freedom Inguinal Hernia Repair System Study
Study Start Date : December 2013
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Freedom ProFlor Inguinal Hernia Implant Device: Freedom ProFlor Inguinal Hernia Implant



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluate the 14-day pain and medication log [ Time Frame: 14 days ]
    Patient will record pain score and medications for 14 consecutive days.


Other Outcome Measures:
  1. Study-related complications/adverse events [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984996


Locations
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United States, California
Metabolic Clinic and Research Center
Los Angeles, California, United States, 90033
United States, Indiana
Witham Health Services
Lebanon, Indiana, United States, 46052
United States, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
United States, North Carolina
New Hannover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Austria
Herz Jesu Krankenhaus GmbH
Wien, Austria, A-1030
Italy
Istituto Clinico Sant'Ambrogio
Milano, Italy, 20149
Azienda Policlinico Umberto I
Roma, Italy, 00161
Policlinico Tor Vergata
Roma, Italy, 00161
Sponsors and Collaborators
Insightra Medical, Inc.
Investigators
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Principal Investigator: Karl LeBlanc, M.D., M.B.A., F.A.C.S. Our Lady of the Lake Regional Medical Center

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Responsible Party: Insightra Medical, Inc.
ClinicalTrials.gov Identifier: NCT01984996     History of Changes
Other Study ID Numbers: P0069
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal