<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/NCT04437680</url>
  </required_header>
  <id_info>
    <org_study_id>DO609635A</org_study_id>
    <nct_id>NCT04437680</nct_id>
  </id_info>
  <brief_title>Retrospective Chart Review Study of Patients Treated With Votiva Device</brief_title>
  <official_title>Retrospective Chart Review Study of Patients Treated With Votiva Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InMode MD Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InMode MD Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      retrospective data collection is to gain insight into patients satisfaction post Votiva&#xD;
      treatments for the complex of vulvovaginal symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Participant satisfaction post treatment</measure>
    <time_frame>4 weeks post treatment</time_frame>
    <description>• Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results [ Time Frame: Baseline to 4 weeks post-treatment/s]</description>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Vulvovaginal Signs and Symptoms</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Votiva device</intervention_name>
    <description>A retrospective chart review of the medical records</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A retrospective chart review of the medical records of 2 practices will be performed by&#xD;
        investigators listed in the approved IRB protocol. Patients are seen at 1 site from August&#xD;
        2018 - May 2020, at 2nd site from September 2018 - February 2020 will be included. Patents&#xD;
        who have received RF treatment with Votiva will be identified and selected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18years of age at the time of the procedure&#xD;
&#xD;
          -  patients with symptoms of at least one of the following: vaginal relaxation syndrome,&#xD;
             vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI,&#xD;
             recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.&#xD;
&#xD;
          -  At least one Votiva procedure that included FormaV applicator treatment with or&#xD;
             without combination with Fractora/Morpheus8 Applicators treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active infection, collagen disorders, immunocompromised state, medications that&#xD;
             mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Advanced Women's Care of the Lowcountry</name>
      <address>
        <city>Hilton Head Island</city>
        <state>South Carolina</state>
        <zip>29926</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Owen Health Group</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 10, 2022</last_update_submitted>
  <last_update_submitted_qc>January 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04437680
org study id: DO609635A
nct id: NCT04437680
lead sponsor: 
has dmc: No
is fda regulated device: Yes
is us export: Yes
retrospective data collection is to gain insight into patients satisfaction post Votiva
      treatments for the complex of vulvovaginal symptoms.
observational model: Case-Only
time perspective: Retrospective
measure: Participant satisfaction post treatment
time frame: 4 weeks post treatment
description: • Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results [ Time Frame: Baseline to 4 weeks post-treatment/s]
intervention type: Device
intervention name: Votiva device
description: A retrospective chart review of the medical records
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No