<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/NCT03750214</url>
  </required_header>
  <id_info>
    <org_study_id>CLP - 430</org_study_id>
    <nct_id>NCT03750214</nct_id>
  </id_info>
  <brief_title>Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)</brief_title>
  <official_title>Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BIOP Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BIOP Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the&#xD;
      safety and performance of the Biop Digital Colposcope and the accuracy of the image&#xD;
      registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope&#xD;
      probe unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the&#xD;
      safety and performance of the Biop Digital Colposcope and the accuracy of the image&#xD;
      registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope&#xD;
      probe unit.&#xD;
&#xD;
      The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina,&#xD;
      cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as&#xD;
      lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are&#xD;
      to be viewed on a color display. The digital colposcope is intended for use in hospitals,&#xD;
      clinics, and doctor's offices.&#xD;
&#xD;
      The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina&#xD;
      for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital&#xD;
      Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The&#xD;
      Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.&#xD;
&#xD;
      It is anticipated that it will take approximately 3 months to complete active enrollment.&#xD;
      Study duration for each subject is 1-2 days, including screening, enrolment and procedure.&#xD;
      The study will be completed when the final study subject has completed the procedure.&#xD;
&#xD;
        1. Performance - to confirm that average image registration error is less than or equal to&#xD;
           (≤) 2mm.&#xD;
&#xD;
        2. Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing&#xD;
           cervical colposcopy procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>procedure day ± 1 day</time_frame>
    <description>The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>frequency and incidence of all Adverse Events</measure>
    <time_frame>procedure day ± 1 day</time_frame>
    <description>Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Exploratory Endpoint</measure>
    <time_frame>procedure day ± 1 day</time_frame>
    <description>Subject's comfort - as measured by a questionnaire</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Cervical Cancer Screening</condition>
  <arm_group>
    <arm_group_label>Biop Coplposcopy System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biop Colposcopy system procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biop Colposcopy System</intervention_name>
    <description>The procedure stages:&#xD;
Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.&#xD;
Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.&#xD;
A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.&#xD;
A questionnaire completed by the user after the Biop procedure, with regards to system usage&#xD;
Image Registration analysis</description>
    <arm_group_label>Biop Coplposcopy System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females, ages 22 to 65 years old&#xD;
&#xD;
          -  Referred for colposcopy, following abnormal cervical cytology&#xD;
&#xD;
          -  Subject provides signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or nursing&#xD;
&#xD;
          -  Currently menstruating&#xD;
&#xD;
          -  Currently has intrauterine device (IUD)&#xD;
&#xD;
          -  Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis,&#xD;
             polycytemia vera.&#xD;
&#xD;
          -  Diagnosed with pathologies that affect blood coagulation, the immune system or&#xD;
             undergoing any treatment that interfere with coagulation or the immune system&#xD;
&#xD;
          -  HIV-positive status&#xD;
&#xD;
          -  Psychological instability, inappropriate attitude or motivation&#xD;
&#xD;
          -  Use of any additional experimental drug or device or participation in another clinical&#xD;
             study within the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females, ages 22 to 65 years old</gender_description>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ram Eitan, Md.</last_name>
    <role>Principal Investigator</role>
    <affiliation>RMC Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dana Raveh Arbel</last_name>
    <phone>972528591891</phone>
    <email>dana@biopmedical.com</email>
  </overall_contact>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03750214
org study id: CLP - 430
nct id: NCT03750214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the
      safety and performance of the Biop Digital Colposcope and the accuracy of the image
      registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope
      probe unit.
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the
      safety and performance of the Biop Digital Colposcope and the accuracy of the image
      registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope
      probe unit.

      The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina,
      cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as
      lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are
      to be viewed on a color display. The digital colposcope is intended for use in hospitals,
      clinics, and doctor's offices.

      The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina
      for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital
      Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The
      Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.

      It is anticipated that it will take approximately 3 months to complete active enrollment.
      Study duration for each subject is 1-2 days, including screening, enrolment and procedure.
      The study will be completed when the final study subject has completed the procedure.

        1. Performance - to confirm that average image registration error is less than or equal to
           (≤) 2mm.

        2. Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing
           cervical colposcopy procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Performance
time frame: procedure day ± 1 day
description: The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.
measure: frequency and incidence of all Adverse Events
time frame: procedure day ± 1 day
description: Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.
measure: Exploratory Endpoint
time frame: procedure day ± 1 day
description: Subject's comfort - as measured by a questionnaire
arm group label: Biop Coplposcopy System
arm group type: Experimental
description: Biop Colposcopy system procedure
intervention type: Device
intervention name: Biop Colposcopy System
description: The procedure stages:
Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.
Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.
A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.
A questionnaire completed by the user after the Biop procedure, with regards to system usage
Image Registration analysis
arm group label: Biop Coplposcopy System
criteria: 
gender: Female
gender based: Yes
gender description: Females, ages 22 to 65 years old
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ram Eitan, Md.
role: Principal Investigator
affiliation: RMC Israel
last name: Dana Raveh Arbel
phone: 972528591891
email: dana@biopmedical.com
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No