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A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ProFlor Hernia Repair System
Lichtenstein hernia repair
Sponsored by
Insightra Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Open Inguinal Hernia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled to undergo routine inguinal hernia repair
  • Male and Female patients between 18 and 65 years old
  • Competent to give consent
  • Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
  • Defect size at operation is between 5mm and 35mm
  • Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
  • Primary hernia at the operative site

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 or Nursing women
  • 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
  • Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type)
  • Neutropenia with absolute neutrophil count (ANC)<500 cells/mm3
  • Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure
  • Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
  • Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device
  • Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
  • Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
  • Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study

Sites / Locations

  • Healing Hands Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ProFlor Hernia Repair System

Lichtenstein Hernia Repair

Arm Description

A 3-D hernia mesh

Using flat polypropylene mesh

Outcomes

Primary Outcome Measures

Evaluate the immediate and short-term amount of pain.
We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
Compare the time required for return to normal activities (work).
We will capture the time required to return to normal activities as indicated by the patient.

Secondary Outcome Measures

Identify any short-term related complication/adverse events associated with the procedures.

Full Information

First Posted
September 8, 2014
Last Updated
January 15, 2016
Sponsor
Insightra Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02240550
Brief Title
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Official Title
A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

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
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.
Detailed Description
The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives. The secondary objective of the study is to identify any short-term study related complications/adverse events. The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone. Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProFlor Hernia Repair System
Arm Type
Active Comparator
Arm Description
A 3-D hernia mesh
Arm Title
Lichtenstein Hernia Repair
Arm Type
Active Comparator
Arm Description
Using flat polypropylene mesh
Intervention Type
Device
Intervention Name(s)
ProFlor Hernia Repair System
Other Intervention Name(s)
3D mesh
Intervention Description
The 3-D hernia mesh will be used in the repair of your inguinal hernia.
Intervention Type
Device
Intervention Name(s)
Lichtenstein hernia repair
Other Intervention Name(s)
Polypropylene
Intervention Description
The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
Primary Outcome Measure Information:
Title
Evaluate the immediate and short-term amount of pain.
Description
We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
Time Frame
1 month
Title
Compare the time required for return to normal activities (work).
Description
We will capture the time required to return to normal activities as indicated by the patient.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Identify any short-term related complication/adverse events associated with the procedures.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo routine inguinal hernia repair Male and Female patients between 18 and 65 years old Competent to give consent Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3) Defect size at operation is between 5mm and 35mm Diagnosed with unilateral, direct, indirect or mixed inguinal hernia Primary hernia at the operative site 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 or Nursing women 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 Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type) Neutropenia with absolute neutrophil count (ANC)<500 cells/mm3 Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT) Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Murphy, MD
Organizational Affiliation
Healing Hands Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healing Hands Clinic
City
Pune
Country
India

12. IPD Sharing Statement

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A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair

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