Freedom Inguinal Hernia Repair System Study

June 7, 2016 updated by: Insightra Medical, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, A-1030
        • Herz Jesu Krankenhaus GmbH
  • Italy
      • Milano, Italy, 20149
        • Istituto Clinico Sant'Ambrogio
      • Roma, Italy, 00161
        • Azienda Policlinico Umberto I
      • Roma, Italy, 00161
        • Policlinico Tor Vergata
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Metabolic Clinic and Research Center
    • Indiana
      • Lebanon, Indiana, United States, 46052
        • Witham Health Services
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medical Center
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • New Hannover Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freedom ProFlor Inguinal Hernia Implant
Device: Freedom ProFlor Inguinal Hernia Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week, 3, 6, 9, 12, 18, 24, and 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the 14-day pain and medication log
Time Frame: 14 days
Patient will record pain score and medications for 14 consecutive days.
14 days

Other Outcome Measures

Outcome Measure
Time Frame
Study-related complications/adverse events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insightra Medical, Inc.

Investigators

  • Principal Investigator: Karl LeBlanc, M.D., M.B.A., F.A.C.S., Our Lady of the Lake Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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