<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/NCT01670630</url>
  </required_header>
  <id_info>
    <org_study_id>CS201202</org_study_id>
    <nct_id>NCT01670630</nct_id>
  </id_info>
  <brief_title>A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix</brief_title>
  <official_title>A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MDI Worldwide LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AdventHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate if a novel sheathed speculum provides improved&#xD;
      visualization of the cervix compared to a standard (&quot;non sheathed&quot;) speculum, and to estimate&#xD;
      if the sheathed speculum causes less discomfort during the examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized trial where physician investigators will perform clinically indicated&#xD;
      vaginal speculum examinations using either a sheathed or a standard plastic speculum, to&#xD;
      determine which speculum provides the best visualization of the cervix. As a secondary&#xD;
      outcome, study participants will record their pain level on a 10-cm visual analogue scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of cervix visualized.</measure>
    <time_frame>During vaginal speculum examination.</time_frame>
    <description>To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of pain during speculum examination.</measure>
    <time_frame>During speculum examination.</time_frame>
    <description>To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Comparison of a Sheathed Versus Standard Plastic Speculum</condition>
  <arm_group>
    <arm_group_label>Sheathed speculum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Investigators will perform a vaginal speculum examination with either a sheathed or a standard (&quot;non sheathed&quot; speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard speculum examination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sheathed speculum examination</intervention_name>
    <arm_group_label>Sheathed speculum</arm_group_label>
    <other_name>speculum</other_name>
    <other_name>sheath</other_name>
    <other_name>ClearSpec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard speculum examination</intervention_name>
    <arm_group_label>Standard speculum examination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing clinically indicated vaginal speculum examination.&#xD;
&#xD;
          -  Subject has had at least 1 prior vaginal deliver &gt; 20 weeks gestational age.&#xD;
&#xD;
          -  Able to read and speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia,&#xD;
             candida, vaginitis, or vulvar dermatologic condition).&#xD;
&#xD;
          -  Menopausal or using hormone replacement therapy.&#xD;
&#xD;
          -  Genital atrophy.&#xD;
&#xD;
          -  Chronic pelvic pain, dyspareunia, or interstitial cystitis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Hill, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AdventHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loch Haven Ob/Gyn Group</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>February 28, 2013</last_update_submitted>
  <last_update_submitted_qc>February 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AdventHealth</investigator_affiliation>
    <investigator_full_name>D. Ashley Hill, MD</investigator_full_name>
    <investigator_title>Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education</investigator_title>
  </responsible_party>
  <keyword>speculum</keyword>
  <keyword>vagina</keyword>
  <keyword>cervix</keyword>
  <keyword>examination</keyword>
  <!-- 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/NCT01670630
org study id: CS201202
nct id: NCT01670630
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to estimate if a novel sheathed speculum provides improved
      visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate
      if the sheathed speculum causes less discomfort during the examination.
This is a randomized trial where physician investigators will perform clinically indicated
      vaginal speculum examinations using either a sheathed or a standard plastic speculum, to
      determine which speculum provides the best visualization of the cervix. As a secondary
      outcome, study participants will record their pain level on a 10-cm visual analogue scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Degree of cervix visualized.
time frame: During vaginal speculum examination.
description: To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
measure: Comparison of pain during speculum examination.
time frame: During speculum examination.
description: To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).
arm group label: Sheathed speculum
arm group type: Active Comparator
description: Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
arm group label: Standard speculum examination
arm group type: Active Comparator
description: Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
intervention type: Procedure
intervention name: Sheathed speculum examination
arm group label: Sheathed speculum
other name: speculum
other name: sheath
other name: ClearSpec
intervention type: Procedure
intervention name: Standard speculum examination
arm group label: Standard speculum examination
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: David A Hill, M.D.
role: Principal Investigator
affiliation: AdventHealth
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: AdventHealth
investigator full name: D. Ashley Hill, MD
investigator title: Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education