<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240550</url>
  </required_header>
  <id_info>
    <org_study_id>P0133</org_study_id>
    <nct_id>NCT02240550</nct_id>
  </id_info>
  <brief_title>A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair</brief_title>
  <official_title>A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insightra Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insightra Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner)&#xD;
      prospective study designed to collect perioperative and postoperative data to compare the QOL&#xD;
      of ProFlor vs. Lichtenstein inguinal hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objectives of this study will be to evaluate the immediate and short-term amount&#xD;
      of post-operative pain, the quality of life (QOL), as well as return to normal activities&#xD;
      (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS)&#xD;
      assessments will be held at regular intervals to evaluate these objectives.&#xD;
&#xD;
      The secondary objective of the study is to identify any short-term study related&#xD;
      complications/adverse events.&#xD;
&#xD;
      The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks.&#xD;
      The first and 4th week's visits are mandatory office visits (if possible). If not available&#xD;
      for office visit, a CCS assessment will be mailed or will be conducted via phone.&#xD;
&#xD;
      Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for&#xD;
      presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead&#xD;
      investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the immediate and short-term amount of pain.</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare the time required for return to normal activities (work).</measure>
    <time_frame>1 month</time_frame>
    <description>We will capture the time required to return to normal activities as indicated by the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify any short-term related complication/adverse events associated with the procedures.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>ProFlor Hernia Repair System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 3-D hernia mesh</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lichtenstein Hernia Repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using flat polypropylene mesh</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProFlor Hernia Repair System</intervention_name>
    <description>The 3-D hernia mesh will be used in the repair of your inguinal hernia.</description>
    <arm_group_label>ProFlor Hernia Repair System</arm_group_label>
    <other_name>3D mesh</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lichtenstein hernia repair</intervention_name>
    <description>The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.</description>
    <arm_group_label>Lichtenstein Hernia Repair</arm_group_label>
    <other_name>Polypropylene</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo routine inguinal hernia repair&#xD;
&#xD;
          -  Male and Female patients between 18 and 65 years old&#xD;
&#xD;
          -  Competent to give consent&#xD;
&#xD;
          -  Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)&#xD;
&#xD;
          -  Defect size at operation is between 5mm and 35mm&#xD;
&#xD;
          -  Diagnosed with unilateral, direct, indirect or mixed inguinal hernia&#xD;
&#xD;
          -  Primary hernia at the operative site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of obvious local or systemic infection&#xD;
&#xD;
          -  Any previous surgery on the hernia operative site&#xD;
&#xD;
          -  Hernia is not in the inguinal area&#xD;
&#xD;
          -  Hernia is not identified as indirect or direct&#xD;
&#xD;
          -  Femoral hernias&#xD;
&#xD;
          -  Known collagen disorder&#xD;
&#xD;
          -  Presenting with unstable angina or NYHA class of IV&#xD;
&#xD;
          -  Known Pregnancy or Nursing women&#xD;
&#xD;
          -  Active drug user&#xD;
&#xD;
          -  Recurrence of a repair by any method&#xD;
&#xD;
          -  Patients with giant inguinoscrotal hernia or abdominal wall defect &gt;35 mm in diameter&#xD;
             - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3&#xD;
&#xD;
          -  Immunosuppression, prednisone&gt;15 mg/day, active chemotherapy&#xD;
&#xD;
          -  End stage renal disease&#xD;
&#xD;
          -  Abdominal ascites&#xD;
&#xD;
          -  Skin infection in area of surgical field&#xD;
&#xD;
          -  BMI &gt;35&#xD;
&#xD;
          -  Peritoneum cannot be closed&#xD;
&#xD;
          -  Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to&#xD;
             cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency&#xD;
             syndrome of any type)&#xD;
&#xD;
          -  Neutropenia with absolute neutrophil count (ANC)&lt;500 cells/mm3&#xD;
&#xD;
          -  Significant of life-threatening condition (e.g., endocarditis) that would confound or&#xD;
             interfere with the procedure&#xD;
&#xD;
          -  Patients that require anticoagulant monitoring with an activated partial&#xD;
             thromboplastin time (aPTT)&#xD;
&#xD;
          -  Patients unwilling to forego blood and/or blood product donation for at least 3 months&#xD;
             from initiation of first study device&#xD;
&#xD;
          -  Treatment with investigational medicinal product within 30 days before enrollment and&#xD;
             for the duration of the study&#xD;
&#xD;
          -  Investigational device present, or removed within 30 days before enrollment, or&#xD;
             presence of device-related infection&#xD;
&#xD;
          -  Patients who the investigator considers unlikely to adhere to the protocol or complete&#xD;
             the clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Murphy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Healing Hands Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healing Hands Clinic</name>
      <address>
        <city>Pune</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Open Inguinal Hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240550
org study id: P0133
nct id: NCT02240550
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evaluate the immediate and short-term amount of pain.
time frame: 1 month
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.
measure: Compare the time required for return to normal activities (work).
time frame: 1 month
description: We will capture the time required to return to normal activities as indicated by the patient.
measure: Identify any short-term related complication/adverse events associated with the procedures.
time frame: 1 month
arm group label: ProFlor Hernia Repair System
arm group type: Active Comparator
description: A 3-D hernia mesh
arm group label: Lichtenstein Hernia Repair
arm group type: Active Comparator
description: Using flat polypropylene mesh
intervention type: Device
intervention name: ProFlor Hernia Repair System
description: The 3-D hernia mesh will be used in the repair of your inguinal hernia.
arm group label: ProFlor Hernia Repair System
other name: 3D mesh
intervention type: Device
intervention name: Lichtenstein hernia repair
description: The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
arm group label: Lichtenstein Hernia Repair
other name: Polypropylene
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: John Murphy, MD
role: Principal Investigator
affiliation: Healing Hands Clinic
facility: 
country: India
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal