<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/NCT02228174</url>
  </required_header>
  <id_info>
    <org_study_id>CL04502</org_study_id>
    <nct_id>NCT02228174</nct_id>
  </id_info>
  <brief_title>Sonography Guided Transcervical Ablation of Uterine Fibroids</brief_title>
  <acronym>SONATA</acronym>
  <official_title>Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynesonics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gynesonics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to establish the safety and effectiveness of the Sonata®&#xD;
      System in the treatment of symptomatic uterine fibroids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this single-arm study, subjects who have symptomatic uterine fibroids will have&#xD;
      transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using&#xD;
      the Gynesonics Sonata System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">October 18, 2017</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>Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score &lt; 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a &quot;scale&quot;. PBAC ≥ 150 is associated with heavy menstrual bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure</measure>
    <time_frame>12 Months</time_frame>
    <description>This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was &quot;no surgical reintervention for HMB due to treatment failure at 12 months&quot;, the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)</measure>
    <time_frame>Each Follow-up Visit through 24 Months</time_frame>
    <description>Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Return to Normal Activity (RTNA) in Days</measure>
    <time_frame>30 Day post-procedure</time_frame>
    <description>Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Treatment Effect (OTE) at 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction With Treatment at 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: &quot;very satisfied&quot;, &quot;moderately satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;moderately dissatisfied&quot;, and &quot;very dissatisfied&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Willingness to Recommend Procedure at 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: &quot;definitely yes&quot;, &quot;probably yes&quot;, &quot;probably no&quot;, and &quot;definitely no&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in General Health State at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Pain</measure>
    <time_frame>Immediately Post-procedure as well as Pre-discharge (Day 0)</time_frame>
    <description>Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Tolerance</measure>
    <time_frame>Post-procedure (Day 0)</time_frame>
    <description>Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were &quot;very tolerable&quot;, &quot;moderately tolerable&quot;, &quot;minimally tolerable&quot;, &quot;intolerable&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Length of Stay</measure>
    <time_frame>Day 0 - Day of Treatment</time_frame>
    <description>Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Pregnancy</measure>
    <time_frame>All Follow-up Visits through 24 Months</time_frame>
    <description>Subjects were asked about the possible occurrence of pregnancy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Outcome - Gestation Age</measure>
    <time_frame>24 Months</time_frame>
    <description>If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Outcome - Birth Weight</measure>
    <time_frame>24 Months</time_frame>
    <description>If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months</measure>
    <time_frame>Baseline and 12 Months</time_frame>
    <description>The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Menorrhagia</condition>
  <arm_group>
    <arm_group_label>Subjects Treated with Sonata</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with Sonata.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrauterine Ultrasound-Guided Radiofreq. Ablation System</intervention_name>
    <description>The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).</description>
    <arm_group_label>Subjects Treated with Sonata</arm_group_label>
    <other_name>Gynesonics Sonata System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  premenopausal&#xD;
&#xD;
          -  ≥ 25 and ≤ 50 years of age at time of enrollment&#xD;
&#xD;
          -  experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3&#xD;
             months&#xD;
&#xD;
          -  between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0&#xD;
             cm and ≤ 5.0 cm&#xD;
&#xD;
          -  at least one type 1, type 2, type 3, or type 2-5 fibroid.&#xD;
&#xD;
          -  PBAC score ≥ 150 and ≤ 500&#xD;
&#xD;
          -  consistent menstrual cycles&#xD;
&#xD;
          -  not at material risk for pregnancy&#xD;
&#xD;
          -  speaks and reads a language for which validated questionnaires are available&#xD;
&#xD;
          -  willing and able to read, understand, and sign the informed consent form, to&#xD;
             participate in the study and to adhere to all study follow-up requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  urgent need for surgery to treat fibroid symptoms&#xD;
&#xD;
          -  desire for current or future childbearing&#xD;
&#xD;
          -  presence of a tubal implant for sterilization&#xD;
&#xD;
          -  postmenopausal by history&#xD;
&#xD;
          -  presence of type 0 fibroids, unless &lt; 1 cm in diameter&#xD;
&#xD;
          -  presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size&#xD;
&#xD;
          -  any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter &gt; 5.0 cm&#xD;
&#xD;
          -  bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type&#xD;
             7&#xD;
&#xD;
          -  exclusive presence of fibroids that are insufficient to explain the severity of&#xD;
             symptoms&#xD;
&#xD;
          -  presence of clinically relevant fibroids that cannot be treated for technical reasons&#xD;
&#xD;
          -  presence of an extrauterine pelvic mass that has not been diagnosed as benign&#xD;
&#xD;
          -  IUD/IUS in situ within the washout period&#xD;
&#xD;
          -  previous procedure for fibroids or heavy menstrual bleeding other than myomectomy&#xD;
&#xD;
          -  myomectomy within 12 months&#xD;
&#xD;
          -  any abnormality of the endometrial cavity that obstructs access of the handpiece&#xD;
&#xD;
          -  contraindication to MRI&#xD;
&#xD;
          -  total uterine volume &gt; 1000 cc&#xD;
&#xD;
          -  clinically significant adenomyosis&#xD;
&#xD;
          -  confirmed or suspected diagnosis of clinically relevant endometriosis&#xD;
&#xD;
          -  one or more clinically relevant fibroids that are significantly calcified.&#xD;
&#xD;
          -  previous pelvic irradiation&#xD;
&#xD;
          -  renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]&#xD;
&#xD;
          -  evidence of disorders of hemostasis (AUB-C)&#xD;
&#xD;
          -  abnormal cervical cytology that is unevaluated or untreated in adherence with national&#xD;
             guidelines&#xD;
&#xD;
          -  endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia&#xD;
&#xD;
          -  confirmed abdominal / pelvic malignancy within the previous five years&#xD;
&#xD;
          -  active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;&#xD;
&#xD;
          -  use of a hormonally-relevant medication within the washout period&#xD;
&#xD;
          -  use of an antifibrinolytic agent while undergoing any screening procedures&#xD;
&#xD;
          -  current use of anticoagulant therapy&#xD;
&#xD;
          -  chronic pelvic pain (disruptive for at least six months) or significant baseline&#xD;
             pelvic or menstrual pain&#xD;
&#xD;
          -  chronic uncontrolled moderate and severe hypertension&#xD;
&#xD;
          -  hypoplastic or otherwise short uterus&#xD;
&#xD;
          -  major medical or psychiatric illness or other factors that may affect general health&#xD;
             or subject's ability to adhere to the follow-up schedule or provide valid subject&#xD;
             self-assessment data&#xD;
&#xD;
          -  any other reason for which the individual study subject is not appropriate or suitable&#xD;
             for participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kelly H. Roy M.D. P.C.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Women's Health Institute</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Services, Inc.</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO Clinical Research, LLC</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visions Clinical Research</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD &amp; Associates</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic, Minimally Invasive Gynecology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basque Women's Care</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Women's Research and Wellness Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee Women's Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willowbend Health and Wellness Associates</name>
      <address>
        <city>Frisco</city>
        <state>Texas</state>
        <zip>75035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. José Eleuterio González&quot; de la Universidad Autónoma de Nuevo León</name>
      <address>
        <city>Monterrey</city>
        <state>N.l.</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>November 26, 2018</results_first_submitted>
  <results_first_submitted_qc>February 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 19, 2019</results_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abnormal Uterine Bleeding associated with fibroids</keyword>
  <keyword>AUB-L</keyword>
  <keyword>Fibroids</keyword>
  <keyword>Heavy menstrual bleeding</keyword>
  <keyword>HMB</keyword>
  <keyword>Myoma</keyword>
  <keyword>Menorrhagia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Menorrhagia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02228174/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 2, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02228174/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sonata</title>
          <description>Subjects treated with the Sonata System.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Population</title>
              <participants_list>
                <participants group_id="P1" count="143">Subjects who didn't become pregnant or diagnosed with an interfering medical condition at 12-months</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Analysis Population was comprised of subjects who were treated and had any post-baseline data.</population>
      <group_list>
        <group group_id="B1">
          <title>Sonata</title>
          <description>Subjects treated with Sonata System.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="147"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.9" spread="4.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pictorial Blood Loss Assessment Chart</title>
          <description>The PBAC is a validated assessment tool to estimate menstrual blood loss using icons representing various degrees of saturation of sanitary products. It is not a scale, but rather an index with values ≤100 to have been reported to represent eumenorrhea. In this study, women had to have heavy menstrual bleeding marked by a baseline PBAC of &gt;=150 and &lt;=500 to be eligible for study participation.</description>
          <units>Index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="300.6" spread="98.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)</title>
        <description>The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score &lt; 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a &quot;scale&quot;. PBAC ≥ 150 is associated with heavy menstrual bleeding.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>Full Analysis Population (143) minus 1 subject who had surgical reintervention prior to 12 months and was excluded from analysis of bleeding reduction coprimary endpoint per the Statistical Analysis Plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)</title>
          <description>The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score &lt; 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a &quot;scale&quot;. PBAC ≥ 150 is associated with heavy menstrual bleeding.</description>
          <population>Full Analysis Population (143) minus 1 subject who had surgical reintervention prior to 12 months and was excluded from analysis of bleeding reduction coprimary endpoint per the Statistical Analysis Plan.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.8" lower_limit="56.3" upper_limit="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure</title>
        <description>This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was &quot;no surgical reintervention for HMB due to treatment failure at 12 months&quot;, the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.</description>
        <time_frame>12 Months</time_frame>
        <population>Full Analysis Population (143 subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure</title>
          <description>This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was &quot;no surgical reintervention for HMB due to treatment failure at 12 months&quot;, the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.</description>
          <population>Full Analysis Population (143 subjects)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="95.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)</title>
        <description>Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.</description>
        <time_frame>Each Follow-up Visit through 24 Months</time_frame>
        <population>Safety population - all subjects who recieved the Sonata treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)</title>
          <description>Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.</description>
          <population>Safety population - all subjects who recieved the Sonata treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months</title>
        <description>The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months</title>
          <description>The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% Change in Total Mean Maximal Fibroid Volume</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.4" spread="32.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% Change in Perfused Mean Maximal Fibroid Volume</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63.9" spread="31.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months</title>
        <description>The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months</title>
          <description>The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>points on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean Change in SSS at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.1" spread="21.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean Change in HR-QoL at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7" spread="24.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Return to Normal Activity (RTNA) in Days</title>
        <description>Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.</description>
        <time_frame>30 Day post-procedure</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Return to Normal Activity (RTNA) in Days</title>
          <description>Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Treatment Effect (OTE) at 12 Months</title>
        <description>The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.</description>
        <time_frame>12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Treatment Effect (OTE) at 12 Months</title>
          <description>The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Fibroid Symptoms Improved</title>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fibroid Symptoms Unchanged</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fibroid Symptoms Worsened</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction With Treatment at 12 Months</title>
        <description>Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: &quot;very satisfied&quot;, &quot;moderately satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;moderately dissatisfied&quot;, and &quot;very dissatisfied&quot;.</description>
        <time_frame>12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction With Treatment at 12 Months</title>
          <description>Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: &quot;very satisfied&quot;, &quot;moderately satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;somewhat dissatisfied&quot;, &quot;moderately dissatisfied&quot;, and &quot;very dissatisfied&quot;.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Modeately Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat Dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately Dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Willingness to Recommend Procedure at 12 Months</title>
        <description>Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: &quot;definitely yes&quot;, &quot;probably yes&quot;, &quot;probably no&quot;, and &quot;definitely no&quot;.</description>
        <time_frame>12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Willingness to Recommend Procedure at 12 Months</title>
          <description>Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: &quot;definitely yes&quot;, &quot;probably yes&quot;, &quot;probably no&quot;, and &quot;definitely no&quot;.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Definitely Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Probably Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Probably No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Definitely No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in General Health State at 12 Months</title>
        <description>Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>Full Analysis Population without imputation for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in General Health State at 12 Months</title>
          <description>Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.</description>
          <population>Full Analysis Population without imputation for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Pain</title>
        <description>Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).</description>
        <time_frame>Immediately Post-procedure as well as Pre-discharge (Day 0)</time_frame>
        <population>Safety Population - all treated subjects (147).</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Pain</title>
          <description>Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).</description>
          <population>Safety Population - all treated subjects (147).</population>
          <units>score on a scale from 0 to 10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Pain During Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Pain During Recovery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="2.771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Tolerance</title>
        <description>Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were &quot;very tolerable&quot;, &quot;moderately tolerable&quot;, &quot;minimally tolerable&quot;, &quot;intolerable&quot;.</description>
        <time_frame>Post-procedure (Day 0)</time_frame>
        <population>Safety Population - all treated subjects (147).</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Tolerance</title>
          <description>Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were &quot;very tolerable&quot;, &quot;moderately tolerable&quot;, &quot;minimally tolerable&quot;, &quot;intolerable&quot;.</description>
          <population>Safety Population - all treated subjects (147).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Tolerable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately Tolerable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimally Tolerable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Intolerable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Length of Stay</title>
        <description>Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.</description>
        <time_frame>Day 0 - Day of Treatment</time_frame>
        <population>Safety Population - all treated subjects (147).</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Length of Stay</title>
          <description>Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.</description>
          <population>Safety Population - all treated subjects (147).</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.54" spread="1.243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Pregnancy</title>
        <description>Subjects were asked about the possible occurrence of pregnancy.</description>
        <time_frame>All Follow-up Visits through 24 Months</time_frame>
        <population>Full Analysis Population (143 subjects).</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Pregnancy</title>
          <description>Subjects were asked about the possible occurrence of pregnancy.</description>
          <population>Full Analysis Population (143 subjects).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pregnancy Outcome - Gestation Age</title>
        <description>If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.</description>
        <time_frame>24 Months</time_frame>
        <population>1 subject with pregnancy</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Pregnancy Outcome - Gestation Age</title>
          <description>If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.</description>
          <population>1 subject with pregnancy</population>
          <units>weeks</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pregnancy Outcome - Birth Weight</title>
        <description>If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.</description>
        <time_frame>24 Months</time_frame>
        <population>1 subject with pregnancy</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Pregnancy Outcome - Birth Weight</title>
          <description>If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.</description>
          <population>1 subject with pregnancy</population>
          <units>grams</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months</title>
        <description>The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.</description>
        <time_frame>Baseline and 12 Months</time_frame>
        <population>Subset of the Full Analysis Population who were employed and had paired responses at baseline and 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Treated With Sonata</title>
            <description>Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months</title>
          <description>The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.</description>
          <population>Subset of the Full Analysis Population who were employed and had paired responses at baseline and 12 months.</population>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in mean Overall Work Impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.0" spread="34.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in mean Activity Impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.2" spread="31.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Months</time_frame>
      <desc>All Adverse Events were evaluated by the Sponsor and reviewed by the study's Medical Advisory Board for relatedness and seriousness.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sonata</title>
          <description>Subjects treated with the Sonata System.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal Discharge with Overnight Hospital Stay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Genitourinary Infections</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cramping/Pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Fibroid Shedding</sub_title>
                <counts group_id="E1" events="53" subjects_affected="45" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Vaginal Discharge</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)</name_or_title>
      <organization>Gynesonics</organization>
      <phone>650-216-3878</phone>
      <email>tfarazi@gynesonics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02228174
org study id: CL04502
nct id: NCT02228174
lead sponsor: 
has dmc: Yes
The objective of this study is to establish the safety and effectiveness of the Sonata®
      System in the treatment of symptomatic uterine fibroids.
In this single-arm study, subjects who have symptomatic uterine fibroids will have
      transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using
      the Gynesonics Sonata System.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
time frame: Baseline and 12 Months
description: The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.
measure: Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
time frame: 12 Months
description: This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.
measure: Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
time frame: Each Follow-up Visit through 24 Months
description: Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.
measure: Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months
time frame: Baseline and 12 Months
description: The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.
measure: Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months
time frame: Baseline and 12 Months
description: The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.
measure: Time to Return to Normal Activity (RTNA) in Days
time frame: 30 Day post-procedure
description: Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.
measure: Overall Treatment Effect (OTE) at 12 Months
time frame: 12 Months
description: The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.
measure: Subject Satisfaction With Treatment at 12 Months
time frame: 12 Months
description: Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: "very satisfied", "moderately satisfied", "somewhat satisfied", "somewhat dissatisfied", "moderately dissatisfied", and "very dissatisfied".
measure: Subject Willingness to Recommend Procedure at 12 Months
time frame: 12 Months
description: Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: "definitely yes", "probably yes", "probably no", and "definitely no".
measure: Change in General Health State at 12 Months
time frame: Baseline and 12 Months
description: Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.
measure: Subject Pain
time frame: Immediately Post-procedure as well as Pre-discharge (Day 0)
description: Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).
measure: Procedure Tolerance
time frame: Post-procedure (Day 0)
description: Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".
measure: Mean Length of Stay
time frame: Day 0 - Day of Treatment
description: Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.
measure: Occurrence of Pregnancy
time frame: All Follow-up Visits through 24 Months
description: Subjects were asked about the possible occurrence of pregnancy.
measure: Pregnancy Outcome - Gestation Age
time frame: 24 Months
description: If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.
measure: Pregnancy Outcome - Birth Weight
time frame: 24 Months
description: If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.
measure: Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months
time frame: Baseline and 12 Months
description: The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.
arm group label: Subjects Treated with Sonata
arm group type: Experimental
description: Intervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with Sonata.
intervention type: Device
intervention name: Intrauterine Ultrasound-Guided Radiofreq. Ablation System
description: The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).
arm group label: Subjects Treated with Sonata
other name: Gynesonics Sonata System
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: No
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country: Mexico
country: United States
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Menorrhagia
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