<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/NCT03280446</url>
  </required_header>
  <id_info>
    <org_study_id>IG-VL-101</org_study_id>
    <nct_id>NCT03280446</nct_id>
  </id_info>
  <brief_title>Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.</brief_title>
  <official_title>Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SHERRY Thomas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency&#xD;
      Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of thirty (30) subjects will be enrolled and assigned to a single treatment arm,&#xD;
      receiving active treatment clinic, with the visits consisting of three (3) treatment&#xD;
      administrations and post-procedure visits days 30, 180 and 360. Pre-menopausal and&#xD;
      post-menopausal women between ages over 18, vaginal delivery, with up to moderate pelvic&#xD;
      prolapse 2 cm past the hymen, and self-reported vaginal laxity score of &quot;very loose&quot;,&#xD;
      moderately loose&quot;, or &quot;slightly loose&quot; as defined by theVaginal Laxity Questionnaire (VLQ)&#xD;
      will be evaluated and enrolled after having met all inclusion and exclusion criteria.&#xD;
&#xD;
      The treatment administration phase will consist of three (3) treatments,delivered&#xD;
      approximately on-month apart. Subjects will be placed on the treatment table in the dorsal&#xD;
      lithotomy position. The monopolar return pad will be placed on the subject buttock and to the&#xD;
      RF generator.Coupling fluid will be used as a lubricant and will be reapplied throughout the&#xD;
      treatment as needed. The treatment area is approximately 20+ cm2 and consist of the outside&#xD;
      perineum and entire vaginal circumference along the length of the vagina to include the apex.&#xD;
      For treatment of the labia majora, the treatment tip will be applied across the entire&#xD;
      anatomical region. The treatment tip is applied to the perineum bilaterally from the lowest&#xD;
      edge of the mons pubis to the perineal body and laterally to the crural folds to achieve&#xD;
      vulvar and perineal temperatures of between 40-45 degrees celsius for approximately 5 minutes&#xD;
      or more of total heat time per area. The labia majora and perineal areas will take&#xD;
      approximately 10-15 minutes to complete. This is followed by treating the epithelial surface&#xD;
      of the vaginal opening and advancing to the length of the vaginal canal with the treatment&#xD;
      occurring along the vaginal walls, floor, and ceiling. The entire vaginal area will be&#xD;
      treated in a circumferential area by delivering the RF in a systematic fashion at 5 separate&#xD;
      delivery position starting the most distal portion of the vagina. The probe is slowly&#xD;
      retracted at 1 cm intervals and circumferentially delivered again at 5 positions on another&#xD;
      circumferentially manner moving the probe clockwise or counter clockwise or counter&#xD;
      clockwise. To include the entire length of the urethra and bladder will be included in the&#xD;
      treatment. Total vaginal treatment time will be 15-20 minutes. Safety measures will include&#xD;
      monitoring of adverse events including pain or burns or infections during and after the&#xD;
      procedure. Evaluations will be conducted with the visits at days 30, 90 and 150 days&#xD;
      post-procedure.&#xD;
&#xD;
      During and after treatment administration, subjects will be asked to assess the self-&#xD;
      reported pain experience using a 10 scale VAS, with &quot;0&quot; being no pain and &quot;10&quot; being the&#xD;
      worst pain imaginable. Descriptive statistics will be generated on all demographic, medical&#xD;
      history, and physical examination findings including means and standard deviations, for&#xD;
      continuous, and frequencies and percentages for categorical variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 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>To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).</measure>
    <time_frame>12 month</time_frame>
    <description>The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to base line.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms.</measure>
    <time_frame>12 month</time_frame>
    <description>To seasures improvement in subject sexual satisfaction and Urogynecological symptoms using sexual satisfaction Questionnaire (SSQ) and GRA (Global Response Assessment)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Vaginal Laxity</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>30 pre-menopause and post-menopause women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty healthy women with mild to moderate pelvic prolapse above the ages of 18 seeking treatment for vaginal laxity</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intragen fractional radiofrequency with NeuViVa</intervention_name>
    <description>The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.</description>
    <arm_group_label>30 pre-menopause and post-menopause women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy female adult subjects presenting, clinically, with VL, and has expressed interest&#xD;
        in treatment will be considered eligible for the study. Enrollment of subject will depend&#xD;
        on meeting the following criteria:&#xD;
&#xD;
          -  Voluntarily signed informed consent form&#xD;
&#xD;
          -  Ages ≥ 18&#xD;
&#xD;
          -  Completed urine pregnancy examination with negative result if premenopausal&#xD;
&#xD;
          -  Self-reported perceptions of vaginal laxity deﬁned as &quot;very loose,&quot; &quot;moderately&#xD;
             loose,&quot; or slightly loose&quot; on the Vaginal Laxity Questionnaire.&#xD;
&#xD;
          -  Up to Baden-Walker Grade 2 or Stage 2 Pelvic Organ Prolapse (≤ 1 cm past hymen)&#xD;
&#xD;
          -  Papanicolaou smear cytology within 36 months prior to treatment showing no dysplasia&#xD;
&#xD;
          -  Subject willing to take valacyclovir at 100 mg PO q12h x 3 for history recurrent&#xD;
             episode of HSV&#xD;
&#xD;
          -  or 1000mg PO q daily x 5 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Baden-Walker System Severe pelvic prolapse (≥ Stage 3); Pelvic organ prolapse up to&#xD;
&#xD;
             1 cm beyond the hymenal ring.&#xD;
&#xD;
          -  Active STD (e.g. genital herpes, condylomata)&#xD;
&#xD;
          -  Body mass index ≥ 35&#xD;
&#xD;
          -  Previous reconstructive vaginal surgery, vaginal lasers, or vaginal injections of fat&#xD;
             or fillers within 6 months.&#xD;
&#xD;
          -  Current urinary tract infection&#xD;
&#xD;
          -  Actively participating in, or planning on participating in, pelvic floor muscle&#xD;
             strengthening exercises.&#xD;
&#xD;
          -  Presence of pacemaker, AICD, or other electrical health maintenance device.&#xD;
&#xD;
          -  Immunosuppression (pathological or medication induced, such as steroids, methotrexate)&#xD;
             inﬂammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can&#xD;
             affect collagen or healing. Subject may qualify if willingly fulﬁlls a 30-day washout&#xD;
             period of such drugs prior to treatment.They were using anti-inﬂammatory drugs on a&#xD;
             chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or&#xD;
             healing. Subject may qualify if willingly fulﬁlls a 30 days washout period of such&#xD;
             drugs prior to treatment.&#xD;
&#xD;
        Those with clinically signiﬁcant anxiety or depression that may prohibit completion of&#xD;
        treatments and/or suffering a medical problem that might interfere with wound healing.&#xD;
&#xD;
        • All subjects on oral contraceptives prior to enrollment are encouraged to take these&#xD;
        throughout the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sherry Thomas, MD</last_name>
    <phone>8189910988</phone>
    <email>drsherrythomas@yahoo.com</email>
  </overall_contact>
  <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>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 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>Sherry Thomas, MD, MPH</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</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/NCT03280446
org study id: IG-VL-101
nct id: NCT03280446
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency
      Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.
A total of thirty (30) subjects will be enrolled and assigned to a single treatment arm,
      receiving active treatment clinic, with the visits consisting of three (3) treatment
      administrations and post-procedure visits days 30, 180 and 360. Pre-menopausal and
      post-menopausal women between ages over 18, vaginal delivery, with up to moderate pelvic
      prolapse 2 cm past the hymen, and self-reported vaginal laxity score of "very loose",
      moderately loose", or "slightly loose" as defined by theVaginal Laxity Questionnaire (VLQ)
      will be evaluated and enrolled after having met all inclusion and exclusion criteria.

      The treatment administration phase will consist of three (3) treatments,delivered
      approximately on-month apart. Subjects will be placed on the treatment table in the dorsal
      lithotomy position. The monopolar return pad will be placed on the subject buttock and to the
      RF generator.Coupling fluid will be used as a lubricant and will be reapplied throughout the
      treatment as needed. The treatment area is approximately 20+ cm2 and consist of the outside
      perineum and entire vaginal circumference along the length of the vagina to include the apex.
      For treatment of the labia majora, the treatment tip will be applied across the entire
      anatomical region. The treatment tip is applied to the perineum bilaterally from the lowest
      edge of the mons pubis to the perineal body and laterally to the crural folds to achieve
      vulvar and perineal temperatures of between 40-45 degrees celsius for approximately 5 minutes
      or more of total heat time per area. The labia majora and perineal areas will take
      approximately 10-15 minutes to complete. This is followed by treating the epithelial surface
      of the vaginal opening and advancing to the length of the vaginal canal with the treatment
      occurring along the vaginal walls, floor, and ceiling. The entire vaginal area will be
      treated in a circumferential area by delivering the RF in a systematic fashion at 5 separate
      delivery position starting the most distal portion of the vagina. The probe is slowly
      retracted at 1 cm intervals and circumferentially delivered again at 5 positions on another
      circumferentially manner moving the probe clockwise or counter clockwise or counter
      clockwise. To include the entire length of the urethra and bladder will be included in the
      treatment. Total vaginal treatment time will be 15-20 minutes. Safety measures will include
      monitoring of adverse events including pain or burns or infections during and after the
      procedure. Evaluations will be conducted with the visits at days 30, 90 and 150 days
      post-procedure.

      During and after treatment administration, subjects will be asked to assess the self-
      reported pain experience using a 10 scale VAS, with "0" being no pain and "10" being the
      worst pain imaginable. Descriptive statistics will be generated on all demographic, medical
      history, and physical examination findings including means and standard deviations, for
      continuous, and frequencies and percentages for categorical variables.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).
time frame: 12 month
description: The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to base line.
measure: To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms.
time frame: 12 month
description: To seasures improvement in subject sexual satisfaction and Urogynecological symptoms using sexual satisfaction Questionnaire (SSQ) and GRA (Global Response Assessment)
arm group label: 30 pre-menopause and post-menopause women
arm group type: Experimental
description: Thirty healthy women with mild to moderate pelvic prolapse above the ages of 18 seeking treatment for vaginal laxity
intervention type: Device
intervention name: Intragen fractional radiofrequency with NeuViVa
description: The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.
arm group label: 30 pre-menopause and post-menopause women
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry Thomas, MD
phone: 8189910988
email: drsherrythomas@yahoo.com
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: Sherry Thomas, MD, MPH
mesh term: Urinary Incontinence
sharing ipd: Undecided