<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/NCT01673698</url>
  </required_header>
  <id_info>
    <org_study_id>The REDUCE Pivotal Trial</org_study_id>
    <nct_id>NCT01673698</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects</brief_title>
  <official_title>A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ReShape Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ReShape Lifesciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific&#xD;
      evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and&#xD;
      exercise in the treatment of obese subjects with one or more obesity-related comorbid&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Group Responder Rate Dichotomized at 25% EWL</measure>
    <time_frame>24 weeks</time_frame>
    <description>An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of &gt;25% EWL at 24 weeks was significantly greater than 35%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight Loss Maintenance Six Months Following Device Removal</measure>
    <time_frame>48 weeks</time_frame>
    <description>Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>ReShape Duo Balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ReShape Duo Balloon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReShape Duo balloon</intervention_name>
    <arm_group_label>ReShape Duo Balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet counseling</intervention_name>
    <arm_group_label>ReShape Duo Balloon</arm_group_label>
    <arm_group_label>Sham Comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise counseling</intervention_name>
    <arm_group_label>ReShape Duo Balloon</arm_group_label>
    <arm_group_label>Sham Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients 21 to 60 years of age&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 30 kg/m^2 and ≤ 40 kg/m^2&#xD;
&#xD;
          -  At least 5 years of obesity (with BMI ≥ 30)&#xD;
&#xD;
          -  Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in&#xD;
             the 3 months preceding the screening assessment&#xD;
&#xD;
          -  Failure to lose weight, within the 36 months preceding the screening date, after&#xD;
             participation in either of the following:&#xD;
&#xD;
               1. A medically or commercially supervised weight loss program involving regular&#xD;
                  counseling regarding both diet and exercise.&#xD;
&#xD;
               2. Use of a United States Food and Drug Administration (FDA)-approved diet drug&#xD;
&#xD;
          -  The presence of one or more obesity-related comorbid conditions&#xD;
&#xD;
          -  Willing and able to provide Informed Consent&#xD;
&#xD;
          -  Willing and able to comply with study procedures and visit schedules as specified by&#xD;
             the protocol&#xD;
&#xD;
          -  If female, the patient must&#xD;
&#xD;
               1. be postmenopausal for at least 1 year OR&#xD;
&#xD;
               2. be surgically sterile, OR&#xD;
&#xD;
               3. if of child bearing potential, must be practicing birth control, be willing to&#xD;
                  avoid pregnancy for the year of study participation, have a negative serum&#xD;
                  pregnancy test at screening, and a negative urine pregnancy test at baseline&#xD;
&#xD;
          -  Residing within a reasonable distance from the Investigator's treating office and able&#xD;
             and willing to travel to the Investigator's office to complete all routine follow-up&#xD;
             visits.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  History of and/or ongoing clinically significant conditions or disorders of the&#xD;
             gastrointestinal (GI) tract&#xD;
&#xD;
          -  Clinically significant and uncontrolled/unstable hepatic, reproductive,&#xD;
             gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory,&#xD;
             endocrine, or cardiovascular system diseases&#xD;
&#xD;
          -  Significant acute and/or chronic infections of any kind.&#xD;
&#xD;
          -  Severe coagulopathy, hepatic insufficiency or cirrhosis&#xD;
&#xD;
          -  Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled&#xD;
             steroid therapy during the anticipated duration of trial participation&#xD;
&#xD;
          -  Severe obstructive sleep apnea&#xD;
&#xD;
          -  Incompletely controlled hypothyroidism or hyperthyroidism&#xD;
&#xD;
          -  Severe systemic disease [consistent with an ASA (American Society of Anesthesia)&#xD;
             Physical Status Classification Score of 3 or greater]&#xD;
&#xD;
          -  Eating disorders, especially binge eating&#xD;
&#xD;
          -  Inability to walk 200 yards without assistance&#xD;
&#xD;
          -  Known allergies to any of the device materials or accessories, i.e. silicone,&#xD;
             methylene blue, corn starch&#xD;
&#xD;
          -  Active drug or alcohol addiction within 12 months of enrollment&#xD;
&#xD;
          -  Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of&#xD;
             requiring insulin treatment in the following 12 months&#xD;
&#xD;
          -  Depressive disorder with total Beck Depression Inventory (BDI) score &gt; 16 points,&#xD;
             and/or BDI affective subscale score &gt; 7 points at screening&#xD;
&#xD;
          -  Ongoing treatment, or anticipated need for such treatment, with anticoagulants, known&#xD;
             gastric irritants such as aspirin (ASA) or non-steroidal anti-inflammatory drugs&#xD;
             (NSAIDs) or agents that can promote gastrointestinal bleeding, within 1 month prior to&#xD;
             enrollment, or unwillingness to forego these medications during the study period&#xD;
&#xD;
          -  Participation within 60 days of screening date in previous or ongoing clinical trial&#xD;
             or current usage of an investigational drug or device&#xD;
&#xD;
          -  Any use of an intragastric device prior to this study.&#xD;
&#xD;
          -  Genetically caused obesity, such as Prader-Willi syndrome&#xD;
&#xD;
          -  Any prior bariatric surgery or likely to undergo bariatric surgery during study&#xD;
             follow-up period&#xD;
&#xD;
          -  Concomitant use of, or unwillingness to avoid any use of, weight loss medications,&#xD;
             weight loss supplements, weight loss herbal preparations and/or participation in any&#xD;
             non-study-related organized weight loss program (commercial or medical) at any time&#xD;
             during the study, including online or smart phone applications to track or modify food&#xD;
             intake, exercise regimens or weight&#xD;
&#xD;
          -  Chronic opiate use (&gt; 3 months continuous use) or likely need for opiate use during&#xD;
             study participation&#xD;
&#xD;
          -  Contraindication or allergy to, or unwillingness to use, proton pump inhibitor&#xD;
             medication throughout study follow-up duration-Pregnancy, breast feeding, or intention&#xD;
             of becoming pregnant during the study&#xD;
&#xD;
          -  Any screening laboratory values outside of the normal range deemed clinically&#xD;
             significant by the Investigator&#xD;
&#xD;
          -  Anemia defined as either:&#xD;
&#xD;
               1. Hemoglobin (Hgb) value for females of &lt; 11.0 g/dl, for males &lt; 12.0 g/dl&#xD;
&#xD;
               2. Abnormal red cell indices and iron deficiency&#xD;
&#xD;
          -  Smoking cessation within 3 months of study entry or plans to quit smoking during the&#xD;
             study&#xD;
&#xD;
          -  Major surgery, open biopsy or significant traumatic injury within 3 months prior to&#xD;
             enrollment.&#xD;
&#xD;
          -  History of significant adverse experience with sedation or anesthesia&#xD;
&#xD;
          -  Serious or uncontrolled psychiatric illness or disorder that could compromise patient&#xD;
             understanding of or compliance with study procedures&#xD;
&#xD;
          -  Any condition that, in the opinion of the Investigator, would compromise the&#xD;
             well-being of the patient or the study or prevent the patient from meeting or&#xD;
             performing study requirements, including:&#xD;
&#xD;
               1. Inability or unwillingness to sign the patient informed consent document.&#xD;
&#xD;
               2. Inability to participate in all necessary study activities due to physical or&#xD;
                  mental limitations.&#xD;
&#xD;
               3. Inability or unwillingness to return for all required follow-up visits.&#xD;
&#xD;
          -  Employees/family members of ReShape Medical® or any of its affiliates or contractors&#xD;
&#xD;
          -  Employees/family members of the Investigator, sub-Investigators, or their medical&#xD;
             office or practice, or surgical, bariatric or hospital organizations at which study&#xD;
             procedures may be performed&#xD;
&#xD;
          -  An immediate family member (by marriage or blood relationship) of another subject&#xD;
             already enrolled in the REDUCE Pivotal Trial&#xD;
&#xD;
        Endoscopic exclusion criteria:&#xD;
&#xD;
          -  Peptic ulcerations&#xD;
&#xD;
          -  Clinically significant hiatal hernia (&gt; 3 cm)&#xD;
&#xD;
          -  Patulous pyloric channel&#xD;
&#xD;
          -  Erosive esophagitis&#xD;
&#xD;
          -  Varices&#xD;
&#xD;
          -  Angiectasias&#xD;
&#xD;
          -  Barrett's esophagus&#xD;
&#xD;
          -  Esophageal stricture&#xD;
&#xD;
          -  Gastric mass&#xD;
&#xD;
          -  Any other subject characteristic that would prevent the successful insertion of a&#xD;
             ReShape Duo™ or that in the opinion of the Investigator preclude safe use of the&#xD;
             ReShape Duo™&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Lehmann, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Lehmann Consulting</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaime Ponce, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamilton Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scottsdale Healthcare</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Medical Center</name>
      <address>
        <city>Dalton</city>
        <state>Georgia</state>
        <zip>30720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marquette General Surgical Weight Loss Center</name>
      <address>
        <city>Marquette</city>
        <state>Michigan</state>
        <zip>49855</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota/Department of Gastrointestinal Surgery</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System</name>
      <address>
        <city>Simpsonville</city>
        <state>South Carolina</state>
        <zip>29680</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midsouth Bariatrics</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of TX Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>August 25, 2015</results_first_submitted>
  <results_first_submitted_qc>November 2, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 7, 2015</results_first_posted>
  <disposition_first_submitted>October 2, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>October 2, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 9, 2014</disposition_first_posted>
  <last_update_submitted>November 2, 2015</last_update_submitted>
  <last_update_submitted_qc>November 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ReShape Duo Balloon</title>
          <description>ReShape Duo Balloon&#xD;
ReShape Duo balloon&#xD;
Diet counseling&#xD;
Exercise counseling</description>
        </group>
        <group group_id="P2">
          <title>Sham Comparator</title>
          <description>Sham Comparator&#xD;
Diet counseling&#xD;
Exercise counseling</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="187"/>
                <participants group_id="P2" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ReShape Duo Balloon</title>
          <description>ReShape Duo Balloon&#xD;
ReShape Duo balloon&#xD;
Diet counseling&#xD;
Exercise counseling</description>
        </group>
        <group group_id="B2">
          <title>Sham Comparator</title>
          <description>Sham Comparator&#xD;
Diet counseling&#xD;
Exercise counseling</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="187"/>
            <count group_id="B2" value="139"/>
            <count group_id="B3" value="326"/>
          </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="43.77" spread="9.51"/>
                    <measurement group_id="B2" value="44.04" spread="10.17"/>
                    <measurement group_id="B3" value="43.88" spread="9.78"/>
                  </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="178"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="310"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="271"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.32" spread="2.84"/>
                    <measurement group_id="B2" value="35.43" spread="2.63"/>
                    <measurement group_id="B3" value="35.37" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24</title>
        <description>An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.</description>
        <time_frame>Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Treatment group</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24</title>
          <description>An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.</description>
          <units>percentage of EWL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" spread="1.596"/>
                    <measurement group_id="O2" value="11.3" spread="1.881"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0041</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Group Responder Rate Dichotomized at 25% EWL</title>
        <description>An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of &gt;25% EWL at 24 weeks was significantly greater than 35%.</description>
        <time_frame>24 weeks</time_frame>
        <population>By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Intent-to-Treat</title>
            <description>Intent-to-Treat population</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Group Responder Rate Dichotomized at 25% EWL</title>
          <description>An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of &gt;25% EWL at 24 weeks was significantly greater than 35%.</description>
          <population>By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Loss Maintenance Six Months Following Device Removal</title>
        <description>Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.</description>
        <time_frame>48 weeks</time_frame>
        <population>By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Intent-to-Treat</title>
            <description>Intent-to-Treat population</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Loss Maintenance Six Months Following Device Removal</title>
          <description>Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.</description>
          <population>By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.</population>
          <units>percentage of participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5610</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Subjects</title>
          <description>Subjects who were randomized and received a balloon during weeks 0-24</description>
        </group>
        <group group_id="E2">
          <title>Control Subjects</title>
          <description>Subjects who were randomized to diet and exercise counseling only during weeks 0-24</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="187"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Esophageal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal hemmorhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Fecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Back injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <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="186" subjects_at_risk="187"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="196" subjects_affected="165" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="134" subjects_affected="104" subjects_at_risk="187"/>
                <counts group_id="E2" events="31" subjects_affected="28" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="124" subjects_affected="110" subjects_at_risk="187"/>
                <counts group_id="E2" events="33" subjects_affected="28" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="73" subjects_affected="72" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="34" subjects_affected="31" subjects_at_risk="187"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="187"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="187"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="187"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="187"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="187"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="187"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="187"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="187"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="187"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="139"/>
              </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>After 12 months after the clinical study report is available, the PI may publish clinical study results, subject to confidentiality agreements and sponsor approval. The PI shall provide sponsor a copy of proposed publication at least 60 days prior to submission so that sponsor may have the opportunity to protect its proprietary rights to information, inventions, or products developed under the clinical study. PI agrees to remove confidential information upon sponsor request.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There are no overall limitations and caveats.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director of Clinical Operations</name_or_title>
      <organization>ReShape Medical</organization>
      <phone>94429-6680</phone>
      <email>lfong@reshapemedical.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/NCT01673698
org study id: The REDUCE Pivotal Trial
nct id: NCT01673698
lead sponsor: 
has dmc: Yes
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific
      evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and
      exercise in the treatment of obese subjects with one or more obesity-related comorbid
      conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
time frame: Week 24
description: An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
measure: Treatment Group Responder Rate Dichotomized at 25% EWL
time frame: 24 weeks
description: An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.
measure: Weight Loss Maintenance Six Months Following Device Removal
time frame: 48 weeks
description: Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.
arm group label: ReShape Duo Balloon
arm group type: Active Comparator
description: ReShape Duo Balloon
arm group label: Sham Comparator
arm group type: Sham Comparator
description: Sham Comparator
intervention type: Device
intervention name: ReShape Duo balloon
arm group label: ReShape Duo Balloon
intervention type: Other
intervention name: Diet counseling
arm group label: ReShape Duo Balloon
arm group label: Sham Comparator
intervention type: Other
intervention name: Exercise counseling
arm group label: ReShape Duo Balloon
arm group label: Sham Comparator
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: John Lehmann, MD, MPH
role: Study Director
affiliation: Lehmann Consulting
last name: Jaime Ponce, MD
role: Principal Investigator
affiliation: Hamilton Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There are no overall limitations and caveats.
point of contact: 