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Freedom Inguinal Hernia Repair System Study

Primary Purpose

Primary Inguinal Hernia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Freedom ProFlor Inguinal Hernia Implant
Sponsored by
Insightra Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metabolic Clinic and Research Center
  • Witham Health Services
  • Our Lady of the Lake Regional Medical Center
  • New Hannover Regional Medical Center
  • Herz Jesu Krankenhaus GmbH
  • Istituto Clinico Sant'Ambrogio
  • Azienda Policlinico Umberto I
  • Policlinico Tor Vergata

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freedom ProFlor Inguinal Hernia Implant

Arm Description

Outcomes

Primary Outcome Measures

Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
Measure quality of life for patients undergoing inguinal hernia repair.

Secondary Outcome Measures

Evaluate the 14-day pain and medication log
Patient will record pain score and medications for 14 consecutive days.

Full Information

First Posted
November 4, 2013
Last Updated
June 7, 2016
Sponsor
Insightra Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01984996
Brief Title
Freedom Inguinal Hernia Repair System Study
Official Title
Freedom Inguinal Hernia Repair System Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Company was dissolved.
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insightra Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Freedom ProFlor Inguinal Hernia Implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Freedom ProFlor Inguinal Hernia Implant
Primary Outcome Measure Information:
Title
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
Description
Measure quality of life for patients undergoing inguinal hernia repair.
Time Frame
1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Secondary Outcome Measure Information:
Title
Evaluate the 14-day pain and medication log
Description
Patient will record pain score and medications for 14 consecutive days.
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Study-related complications/adverse events
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl LeBlanc, M.D., M.B.A., F.A.C.S.
Organizational Affiliation
Our Lady of the Lake Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metabolic Clinic and Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Witham Health Services
City
Lebanon
State/Province
Indiana
ZIP/Postal Code
46052
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
New Hannover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Herz Jesu Krankenhaus GmbH
City
Wien
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
Istituto Clinico Sant'Ambrogio
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

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Freedom Inguinal Hernia Repair System Study

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