<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/NCT03028636</url>
  </required_header>
  <id_info>
    <org_study_id>CA006</org_study_id>
    <nct_id>NCT03028636</nct_id>
  </id_info>
  <brief_title>LIBERATE - PRO: Eclipse™ System Registry</brief_title>
  <acronym>LIBERATEPRO</acronym>
  <official_title>LIBERATE - PRO: An Extended Use Registry to Further Develop Understanding of the Long Term Use of the Eclipse™ System for Fecal Incontinence in Women Via Patient Reported Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pelvalon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pelvalon, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, open label post market registry to collect Patient Reported Outcomes in an&#xD;
      online data capture registry, maintained by Pelvalon, of women with fecal incontinence&#xD;
      exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All LIBERATE (NCT02428595) study participants who complete the 12 month visit will be invited&#xD;
      to participate in the LIBERATE-PRO post market registry in an effort to obtain additional&#xD;
      long term quality of life and economic data. Subjects will be sent an email with a link to&#xD;
      the survey(s) or mailed printed surveys depending on chosen survey delivery option to be&#xD;
      completed at 3, 6, 9, and 12 months.Baseline will be defined as the baseline value in the&#xD;
      LIBERATE study, prior to the insertion of the Eclipse System.&#xD;
&#xD;
      The St. Mark's (Vaizey) Incontinence Severity Score will be used to assess the severity of&#xD;
      accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to&#xD;
      joining the LIBERATE study. The score is based on 7 questions and is a measure of severity of&#xD;
      fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in&#xD;
      frequency of FI episodes and subjects' perceptions of relief. The composite score calculated&#xD;
      from these questions reflects the severity of FI and ranges from 0 (complete continence) to&#xD;
      24 (complete incontinence). The change from baseline score will be calculated at each time&#xD;
      point. The average change from baseline score, computed as the mean change from baseline&#xD;
      across all completed assessments, will be calculated.&#xD;
&#xD;
      The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate&#xD;
      the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much&#xD;
      worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9,&#xD;
      and 12 months in comparison to how it was prior to joining the LIBERATE study. The average&#xD;
      PGI-I score, computed as the mean score across all completed assessments, will be calculated.&#xD;
&#xD;
      The FIQOL (Fecal Incontinence Quality of Life Questionnaire will be completed at 12 months.&#xD;
      The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire&#xD;
      completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior,&#xD;
      depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1&#xD;
      indicating a lower functional status of quality of life. FIQOL score will be used to assess&#xD;
      the changes in quality of life in each of the subscales in comparison to the same scores&#xD;
      prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores&#xD;
      (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated.&#xD;
&#xD;
      The Eclipse Experience feedback (questions related to perceptions of device comfort,&#xD;
      satisfaction with usage and features, and impact on daily activities) will be collected at 3,&#xD;
      6, 9, and 12 months.&#xD;
&#xD;
      All outcomes will be summarized descriptively at each time point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2016</start_date>
  <completion_date type="Actual">February 27, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score</measure>
    <time_frame>3, 6, 9, and 12 months</time_frame>
    <description>The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score</measure>
    <time_frame>3, 6, 9, and 12 months</time_frame>
    <description>The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score</measure>
    <time_frame>12 months</time_frame>
    <description>The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.</description>
  </other_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Fecal Incontinence</condition>
  <condition>Bowel Dysfunction</condition>
  <condition>Bowel Incontinence</condition>
  <condition>Accidental Bowel Leakage</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects exiting the LIBERATE study who are continuing to use the Eclipse System. Since all&#xD;
        of the women in the prior LIBERATE study had to be over the age of 19 to participate in it,&#xD;
        this means that all subjects in the registry will be over the age of 19 by default. For&#xD;
        information about the LIBERATE study including inclusion/exclusion criteria please see&#xD;
        NCT02428595.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has completed the 12-month visit in the LIBERATE study (NCT02428595)&#xD;
&#xD;
          -  Subject has elected to continue to use the Eclipse System outside of the LIBERATE&#xD;
             study&#xD;
&#xD;
          -  Subject provides electronic informed consent and HIPAA authorization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        There are no specific exclusions as this is a data collection registry on a commercially&#xD;
        approved product&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gena Dunivan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pelvalon Inc.; University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pelvalon, Inc.</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT02428595</url>
    <description>LIBERATE Clinical Trials.gov listing</description>
  </link>
  <link>
    <url>http://eclipsesystem.com/</url>
    <description>Pelvalon, Eclipse manufacturer and Study Sponsor, website</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>January 16, 2020</results_first_submitted>
  <results_first_submitted_qc>January 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 28, 2020</results_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fecal incontinence</keyword>
  <keyword>bowel control</keyword>
  <keyword>accidental bowel leakage</keyword>
  <keyword>medical device</keyword>
  <keyword>women's health</keyword>
  <keyword>vaginal insert</keyword>
  <keyword>pessary</keyword>
  <keyword>incontinence</keyword>
  <keyword>bowel continence</keyword>
  <keyword>pump</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03028636/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Subjects</title>
          <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
Surveys were completed at 3, 6, 9, and 12 months during the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </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="66.2" spread="13.2"/>
                  </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="17"/>
                  </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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Menopausal Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-menopause</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Peri-menopause</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-menopause</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score</title>
        <description>The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.</description>
        <time_frame>3, 6, 9, and 12 months</time_frame>
        <population>The number analyzed for each time point is the number of participants who provided a survey. Some participants provided surveys for some but not all time points.</population>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
Surveys were completed at 3, 6, 9, and 12 months during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score</title>
          <description>The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.</description>
          <population>The number analyzed for each time point is the number of participants who provided a survey. Some participants provided surveys for some but not all time points.</population>
          <units>Score 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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Score at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.58" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Score at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.47" spread="5.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Score at 9 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.57" spread="6.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Score at 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.64" spread="6.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score</title>
        <description>The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.</description>
        <time_frame>3, 6, 9, and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects at 3 Months</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
This arm represents patients who completed surveys 3 months into the study.</description>
          </group>
          <group group_id="O2">
            <title>All Subjects at 6 Months</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
This arm represents patients who completed surveys 6 months into the study.</description>
          </group>
          <group group_id="O3">
            <title>All Subjects at 9 Months</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
This arm represents patients who completed surveys 9 months into the study.</description>
          </group>
          <group group_id="O4">
            <title>All Subjects at 12 Months</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.&#xD;
This arm represents patients who completed surveys 12 months into the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score</title>
          <description>The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Much Better (1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Much Better (2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A Little Better (3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change (4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A Little Worse (5)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Much Worse (6)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Much Worse (7)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score</title>
        <description>The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.</description>
          </group>
        </group_list>
        <measure>
          <title>The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score</title>
          <description>The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.</description>
          <units>Score 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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in Lifestyle Subscale score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".74" spread=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Coping/Behavior Subscale score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".87" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Depression/Self Perception Subscalescore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".94" spread=".51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Embarrassment Subscale score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".76" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported for the entirety of the study, for 12 months of patient treatment. Data was collected for a total of 24 months across all patients.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Subjects</title>
          <description>Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study.&#xD;
In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.</description>
        </group>
      </group_list>
      <serious_events>
        <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="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Management</name_or_title>
      <organization>Pelvalon</organization>
      <phone>650-276-0130</phone>
      <email>steve@pelvalon.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/NCT03028636
org study id: CA006
nct id: NCT03028636
lead sponsor: 
has dmc: No
A prospective, open label post market registry to collect Patient Reported Outcomes in an
      online data capture registry, maintained by Pelvalon, of women with fecal incontinence
      exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel
      control.
All LIBERATE (NCT02428595) study participants who complete the 12 month visit will be invited
      to participate in the LIBERATE-PRO post market registry in an effort to obtain additional
      long term quality of life and economic data. Subjects will be sent an email with a link to
      the survey(s) or mailed printed surveys depending on chosen survey delivery option to be
      completed at 3, 6, 9, and 12 months.Baseline will be defined as the baseline value in the
      LIBERATE study, prior to the insertion of the Eclipse System.

      The St. Mark's (Vaizey) Incontinence Severity Score will be used to assess the severity of
      accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to
      joining the LIBERATE study. The score is based on 7 questions and is a measure of severity of
      fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in
      frequency of FI episodes and subjects' perceptions of relief. The composite score calculated
      from these questions reflects the severity of FI and ranges from 0 (complete continence) to
      24 (complete incontinence). The change from baseline score will be calculated at each time
      point. The average change from baseline score, computed as the mean change from baseline
      across all completed assessments, will be calculated.

      The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate
      the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much
      worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9,
      and 12 months in comparison to how it was prior to joining the LIBERATE study. The average
      PGI-I score, computed as the mean score across all completed assessments, will be calculated.

      The FIQOL (Fecal Incontinence Quality of Life Questionnaire will be completed at 12 months.
      The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire
      completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior,
      depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1
      indicating a lower functional status of quality of life. FIQOL score will be used to assess
      the changes in quality of life in each of the subscales in comparison to the same scores
      prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores
      (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated.

      The Eclipse Experience feedback (questions related to perceptions of device comfort,
      satisfaction with usage and features, and impact on daily activities) will be collected at 3,
      6, 9, and 12 months.

      All outcomes will be summarized descriptively at each time point.
observational model: Cohort
time perspective: Prospective
measure: The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score
time frame: 3, 6, 9, and 12 months
description: The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.
measure: Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score
time frame: 3, 6, 9, and 12 months
description: The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.
measure: The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score
time frame: 12 months
description: The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Gena Dunivan, MD
role: Principal Investigator
affiliation: Pelvalon Inc.; University of New Mexico
facility: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT02428595
description: LIBERATE Clinical Trials.gov listing
url: http://eclipsesystem.com/
description: Pelvalon, Eclipse manufacturer and Study Sponsor, website
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Intestinal Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 