<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/NCT03271944</url>
  </required_header>
  <id_info>
    <org_study_id>20161370</org_study_id>
    <nct_id>NCT03271944</nct_id>
  </id_info>
  <brief_title>Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy</brief_title>
  <official_title>Fractional Handpiece With CO2 Laser: Fractional Ablative Laser Treatment of Vulvovaginal Atrophy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SHERRY Thomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Perigree Medical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The American Association of Female Pelvic Medicine Specialists, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of&#xD;
      vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient&#xD;
      VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal&#xD;
      dryness by means of a visual analogic scale (10 cm VAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the use of a CO2 laser (EdgeTM CO2 Laser) with a&#xD;
      fractional handpiece made specifically for the vagina to possibly restore the normal&#xD;
      physiological conditions of the vagina, thus reducing the symptoms of VVA. The EdgeTM CO2&#xD;
      Laser and general fractional handpiece is approved by the FDA for ablative skin resurfacing&#xD;
      (for example, treating fine lines and wrinkles, acne and surgical scars, skin pigmentation&#xD;
      and discoloration, sun damage, pre-cancerous as well as benign lesions and uneven skin&#xD;
      texture). The fractional handpiece used in this study for the treatment of VVA is&#xD;
      experimental and has not been approved by the FDA for vaginal dryness associated with&#xD;
      menopause.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).</measure>
    <time_frame>9 month</time_frame>
    <description>The purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Vulvovaginal Atrophy</condition>
  <arm_group>
    <arm_group_label>Single group 30 post menopause females.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CO2 Laser Treatment</intervention_name>
    <description>Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy</description>
    <arm_group_label>Single group 30 post menopause females.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting the following inclusion criteria may participate:&#xD;
&#xD;
               -  Healthy non-smoking post menopausal women with absence of menstruation of at&#xD;
                  least 12 months&#xD;
&#xD;
               -  Exhibiting VVA symptoms&#xD;
&#xD;
               -  Prolapse staged &lt; II, according to the pelvic organ prolapse quantification&#xD;
                  (ICS-POP- Q) system&#xD;
&#xD;
               -  Have not had procedures in the anatomical area through 6 months prior to&#xD;
                  treatment&#xD;
&#xD;
               -  Understand and accept the obligation and is logistically able to present for all&#xD;
                  scheduled follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting any of the following criteria will be excluded from participation:&#xD;
&#xD;
               -  Acute or recurrent urinary tract infection (UTI), or genital infection (e.g.&#xD;
                  herpes candida).&#xD;
&#xD;
               -  Prolapse staged ≥ II, according to the pelvic organ prolapse quantification&#xD;
                  (ICS-POP- Q) system&#xD;
&#xD;
               -  Any serious disease, or chronic condition, that could interfere with the study&#xD;
                  compliance&#xD;
&#xD;
               -  Previously undergone reconstructive pelvic surgery&#xD;
&#xD;
               -  Have used vaginal creams, moisturizers, lubricants or homeopathic preparations&#xD;
                  for at least 3 months&#xD;
&#xD;
               -  A history of thrombophlebitis&#xD;
&#xD;
               -  A history of acute infections&#xD;
&#xD;
               -  A history of heart failure&#xD;
&#xD;
               -  Received or is anticipated to receive antiplatelets, anticoagulants,&#xD;
                  thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment&#xD;
&#xD;
               -  Any medical condition, that, in the investigator's opinion would interfere with&#xD;
                  the patient's participation in the study&#xD;
&#xD;
               -  Taking medications that are photosensitive&#xD;
&#xD;
               -  A history of keloid formation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The American Association of Female Pelvic Medicine Specialists, Inc.</name>
      <address>
        <city>Agoura Hills</city>
        <state>California</state>
        <zip>91301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Thomas, MD</last_name>
      <phone>818-991-0988</phone>
      <email>drsherrythomas@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Sharan Dhaliwal</last_name>
      <phone>8189910988</phone>
    </contact_backup>
    <investigator>
      <last_name>Sherry Thomas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The American Association of Female Pelvic Medicine Specialists, Inc.</investigator_affiliation>
    <investigator_full_name>SHERRY Thomas</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03271944
org study id: 20161370
nct id: NCT03271944
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of
      vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient
      VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal
      dryness by means of a visual analogic scale (10 cm VAS).
The purpose of this study is to evaluate the use of a CO2 laser (EdgeTM CO2 Laser) with a
      fractional handpiece made specifically for the vagina to possibly restore the normal
      physiological conditions of the vagina, thus reducing the symptoms of VVA. The EdgeTM CO2
      Laser and general fractional handpiece is approved by the FDA for ablative skin resurfacing
      (for example, treating fine lines and wrinkles, acne and surgical scars, skin pigmentation
      and discoloration, sun damage, pre-cancerous as well as benign lesions and uneven skin
      texture). The fractional handpiece used in this study for the treatment of VVA is
      experimental and has not been approved by the FDA for vaginal dryness associated with
      menopause.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy (VVA).
time frame: 9 month
description: The purpose of this study is to evaluate efficacy and safety of CO2 laser (EdgeTM CO2 Laser) with a fractional headpiece in the treatment of vulvovaginal atrophy (VVA) in post- menopausal women and its effect on the patient VHIS (vaginal health index score). The primary endpoint is to assess the changes in the vaginal dryness by mean of a visual analog scale (10 cm VAS).
arm group label: Single group 30 post menopause females.
arm group type: Other
intervention type: Device
intervention name: CO2 Laser Treatment
description: Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy
arm group label: Single group 30 post menopause females.
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: The American Association of Female Pelvic Medicine Specialists, Inc.
investigator full name: SHERRY Thomas
investigator title: Principal Investigator
mesh term: Atrophy
sharing ipd: Undecided