<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/NCT02235870</url>
  </required_header>
  <id_info>
    <org_study_id>PTL-1100-0013</org_study_id>
    <nct_id>NCT02235870</nct_id>
  </id_info>
  <brief_title>Obalon Balloon System Pivotal IDE (SMART) Trial</brief_title>
  <acronym>SMART</acronym>
  <official_title>The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Obalon Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Obalon Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pivotal trial of the Obalon Balloon System is intended to generate safety and&#xD;
      effectiveness data required to support a future marketing application. The trial has been&#xD;
      designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition&#xD;
      and lifestyle behavior modification program.&#xD;
&#xD;
      Weight loss will be evaluated after the 6-month course to determine if a specific predefined&#xD;
      superiority margin can be achieved in the device group compared to a sham-control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)</measure>
    <time_frame>6 months</time_frame>
    <description>Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group</measure>
    <time_frame>6 Months</time_frame>
    <description>Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">711</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Obalon Intragastric Balloons</intervention_name>
    <description>Intragastric Balloon System to aid in portion control.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Device</intervention_name>
    <description>Sham Intragastric Balloon</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition and Lifestyle Program</intervention_name>
    <description>Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between the ages of 22-64 years&#xD;
&#xD;
          2. Current BMI of 30.0 - 40 kg/m2&#xD;
&#xD;
          3. Previously attempted to lose weight unsuccessfully using a medically supervised or&#xD;
             non-medically supervised diet&#xD;
&#xD;
          4. Willing to attend all protocol-specified follow-up visits plus any additional&#xD;
             follow-up visits as required throughout the entire study period&#xD;
&#xD;
          5. Willing to avoid non-commercial air travel and scuba diving during the entire study&#xD;
             period&#xD;
&#xD;
          6. Willing to avoid medications or other substances known to effect weight changes during&#xD;
             the study&#xD;
&#xD;
          7. Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications&#xD;
             known to be gastric irritants during the study&#xD;
&#xD;
          8. Willing to use contraception and avoid pregnancy during the study if the subject is&#xD;
             female with child bearing potential&#xD;
&#xD;
          9. Willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant weight loss in the past 12 months&#xD;
&#xD;
          2. Use of medications or other substances known to induce weight gain or weight loss&#xD;
&#xD;
          3. Participation in any clinical study at the start of this trial or in the last year&#xD;
&#xD;
          4. Known history of endocrine disorders affecting weight&#xD;
&#xD;
          5. Currently receiving chronic steroid or immunosuppressive therapy or has previously&#xD;
             been diagnosed with HIV&#xD;
&#xD;
          6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid&#xD;
             calorie intake habits or similar eating related psychological disorders&#xD;
&#xD;
          7. Intent to undergo gastric surgery or gastric banding during the study period or within&#xD;
             the 6 month period after completion of this study&#xD;
&#xD;
          8. Prior use of any weight loss medical device&#xD;
&#xD;
          9. Known history of structural or functional disorders of the esophagus&#xD;
&#xD;
         10. Known history of structural or functional disorder of the esophagus, including any&#xD;
             swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal&#xD;
             reflux symptoms&#xD;
&#xD;
         11. Known history of structural or functional disorders of the stomach&#xD;
&#xD;
         12. Known history of a structural or functional disorder of the stomach, including any&#xD;
             symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic&#xD;
             dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or&#xD;
             pain, post-prandial nausea or vomiting or early satiety&#xD;
&#xD;
         13. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal&#xD;
             varices, intestinal stricture/stenosis, small bowel obstruction, or any other&#xD;
             obstructive disorder of the gastrointestinal (GI) tract&#xD;
&#xD;
         14. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction,&#xD;
             such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting&#xD;
&#xD;
         15. Known history irritable bowel syndrome, radiation enteritis or other inflammatory&#xD;
             bowel disease, such as Crohn's disease&#xD;
&#xD;
         16. Known history of GI surgeries that may have resulted in anatomical GI tract&#xD;
             abnormalities&#xD;
&#xD;
         17. Type 1 diabetes&#xD;
&#xD;
         18. Type 2 diabetes requiring insulin or other hypoglycemic oral agents.&#xD;
&#xD;
         19. Experienced a myocardial infarction, has a known history of angina, a known history of&#xD;
             congestive heart failure, or is currently being medically treated for any other&#xD;
             cardiac condition&#xD;
&#xD;
         20. Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).&#xD;
&#xD;
         21. End stage renal disease or requiring hemodialysis within the past 6 months&#xD;
&#xD;
         22. Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including&#xD;
             Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric&#xD;
             irritants beginning two weeks prior to enrollment and throughout the entire study&#xD;
             period&#xD;
&#xD;
         23. Subjects taking medications on specified hourly intervals that may be affected by&#xD;
             changes to gastric emptying&#xD;
&#xD;
         24. Subjects requiring the use of anti-platelet drugs or other agents affecting the normal&#xD;
             clotting of blood&#xD;
&#xD;
         25. Untreated or unstable alcohol or illicit drug addiction&#xD;
&#xD;
         26. Known history of allergies to any component of the device materials&#xD;
&#xD;
         27. Currently pregnant or breastfeeding or intention of becoming pregnant during the study&#xD;
&#xD;
         28. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical&#xD;
             condition, in the opinion of the investigator&#xD;
&#xD;
         29. Subject is employed by the investigator, or is a close relative of the investigator,&#xD;
             or the investigator's staff&#xD;
&#xD;
         30. Subject is a close relative of another subject already enrolled in the study.&#xD;
&#xD;
         31. Any other condition that, in the opinion of the investigator, would interfere with&#xD;
             subject participation, may confound the study results, or interfere with compliance&#xD;
             with the study (e.g., psychosocial issues).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy VandenBerg</last_name>
    <role>Study Chair</role>
    <affiliation>Obalon Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research Center</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bariatric Institute of Greater Chicago</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoscopic Microsurgery Associates</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Hospital in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook Medicine</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Penn Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chattanooga Bariatrics</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midsouth Bariatrics</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>June 28, 2017</results_first_submitted>
  <results_first_submitted_qc>February 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2018</results_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weight Loss</keyword>
  <keyword>Obesity</keyword>
  <keyword>BMI</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>
      <recruitment_details>711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process</recruitment_details>
      <pre_assignment_details>430 subjects randomized in a Treatment or Control group, 387 subjects received an Obalon Balloon or Sham Device.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Obalon Treatment Group</title>
          <description>Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
        </group>
        <group group_id="P2">
          <title>Sham Control Group</title>
          <description>Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="189"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Phase I (Week 24)</title>
              <participants_list>
                <participants group_id="P1" count="182"/>
                <participants group_id="P2" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Crossover (Week 24)</title>
              <participants_list>
                <participants group_id="P1" count="170"/>
                <participants group_id="P2" count="138"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Obalon Treatment Group</title>
          <description>Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
        </group>
        <group group_id="B2">
          <title>Sham Control Group</title>
          <description>Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</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="198"/>
            <count group_id="B2" value="189"/>
            <count group_id="B3" value="387"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.6" spread="9.6"/>
                    <measurement group_id="B2" value="42.5" spread="9.3"/>
                    <measurement group_id="B3" value="42.6" spread="9.4"/>
                  </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="171"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="341"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="46"/>
                  </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="24"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="183"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="348"/>
                  </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="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="21"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="320"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </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>Body Mass Index (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="35.2" spread="2.7"/>
                    <measurement group_id="B2" value="35.5" spread="2.7"/>
                    <measurement group_id="B3" value="35.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups</title>
        <description>Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin</description>
        <time_frame>24 Weeks</time_frame>
        <population>Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Obalon Treatment Group</title>
            <description>Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups</title>
          <description>Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin</description>
          <population>Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks</population>
          <units>%TBL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.86" spread="0.37"/>
                    <measurement group_id="O2" value="3.59" spread="0.37"/>
                  </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</non_inferiority_type>
            <p_value>0.0261</p_value>
            <method>ANCOVA</method>
            <param_type>Least-Square Mean Difference</param_type>
            <param_value>3.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.24</ci_lower_limit>
            <ci_upper_limit>4.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)</title>
        <description>Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%</description>
        <time_frame>6 months</time_frame>
        <population>Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Obalon Treatment Group</title>
            <description>Subjects who received the Obalon Balloons.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)</title>
          <description>Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%</description>
          <population>Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Exact Test</method>
            <param_type>Exact Confidence Interval</param_type>
            <param_value>64.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>57.5</ci_lower_limit>
            <ci_upper_limit>71.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group</title>
        <description>Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)</description>
        <time_frame>6 Months</time_frame>
        <population>Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Obalon Treatment Group</title>
            <description>Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Sham Control Group</title>
            <description>Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group</title>
          <description>Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)</description>
          <population>Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="58"/>
                  </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</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
            <param_type>Percentage Difference</param_type>
            <param_value>32.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.1</ci_lower_limit>
            <ci_upper_limit>42.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Six months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treated Subjects</title>
          <description>Treated subjects include the 198 subjects in Phase I of the study who received at least 1 Obalon Balloon and the 138 subjects in Phase II who crossover and received at least 1 Obalon Balloon</description>
        </group>
        <group group_id="E2">
          <title>Control Subjects</title>
          <description>Control subjects include the 189 subjects in Phase I of the study who received at least 1 Sham Device and the 170 subjects in Phase II who were followed after balloon removal</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="336"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Chiari Malformation</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peptic ulcer disease</sub_title>
                <description>Device or Procedure Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Heel Exostosis</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Bacterial Meningitis</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Pap Smear</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Synovectomy</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="336"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Knee Arthroplasty</sub_title>
                <description>NOT Device or Procedure Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="321" subjects_at_risk="336"/>
                <counts group_id="E2" subjects_affected="221" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 244/336 (76.62%) / 494 Events</description>
                <counts group_id="E1" events="501" subjects_affected="246" subjects_at_risk="336"/>
                <counts group_id="E2" events="65" subjects_affected="51" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 188/336 (55.95%) / 311 Events</description>
                <counts group_id="E1" events="315" subjects_affected="191" subjects_at_risk="336"/>
                <counts group_id="E2" events="43" subjects_affected="37" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 58/336 (17.26%) / 71 Events</description>
                <counts group_id="E1" events="75" subjects_affected="61" subjects_at_risk="336"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 57/336 (16.96%) / 69 Events</description>
                <counts group_id="E1" events="73" subjects_affected="60" subjects_at_risk="336"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 49/336 (14.58%) / 54 Events</description>
                <counts group_id="E1" events="54" subjects_affected="49" subjects_at_risk="336"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 31/336 (9.23%) / 37 Events</description>
                <counts group_id="E1" events="37" subjects_affected="31" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 28/336 (8.33%) / 30 Events</description>
                <counts group_id="E1" events="47" subjects_affected="41" subjects_at_risk="336"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Gastric Irritation</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 24/336 (7.14%) / 25 Events</description>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Gastric Bleeding/Abrasion</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 17/336 (5.06%) / 17 Events</description>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="336"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 9/336 (2.68%) / 10 Events</description>
                <counts group_id="E1" events="57" subjects_affected="51" subjects_at_risk="336"/>
                <counts group_id="E2" events="47" subjects_affected="37" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Common Cold/Upper Respiratory Infection</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events</description>
                <counts group_id="E1" events="56" subjects_affected="46" subjects_at_risk="336"/>
                <counts group_id="E2" events="50" subjects_affected="44" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Stomach/Seasonal Flu</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 0/336 (0.00%) / 0 Events</description>
                <counts group_id="E1" events="32" subjects_affected="29" subjects_at_risk="336"/>
                <counts group_id="E2" events="28" subjects_affected="25" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Headache/Migraine</sub_title>
                <description>Treated Subjects - Device or Procedure Related Only (FDA Reviewed): 6/336 (1.79%) / 7 Events</description>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="336"/>
                <counts group_id="E2" events="30" subjects_affected="26" subjects_at_risk="359"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Amy VandenBerg, Vice-President, Clinical Affairs and Regulatory Affairs</name_or_title>
      <organization>Obalon Therapeutics, Inc.</organization>
      <phone>760.795.6551</phone>
      <email>avandenberg@obalon.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/NCT02235870
org study id: PTL-1100-0013
nct id: NCT02235870
lead sponsor: 
has dmc: No
This pivotal trial of the Obalon Balloon System is intended to generate safety and
      effectiveness data required to support a future marketing application. The trial has been
      designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition
      and lifestyle behavior modification program.

      Weight loss will be evaluated after the 6-month course to determine if a specific predefined
      superiority margin can be achieved in the device group compared to a sham-control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
time frame: 24 Weeks
description: Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
measure: Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
time frame: 6 months
description: Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%
measure: Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
time frame: 6 Months
description: Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)
arm group label: Treatment Group
arm group type: Active Comparator
description: In accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy.
arm group label: Control Group
arm group type: Sham Comparator
description: Control arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy.
intervention type: Device
intervention name: Obalon Intragastric Balloons
description: Intragastric Balloon System to aid in portion control.
arm group label: Treatment Group
intervention type: Device
intervention name: Sham Device
description: Sham Intragastric Balloon
arm group label: Control Group
intervention type: Behavioral
intervention name: Nutrition and Lifestyle Program
description: Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
arm group label: Control Group
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 22 Years
maximum age: 64 Years
healthy volunteers: No
last name: Amy VandenBerg
role: Study Chair
affiliation: Obalon Therapeutics, Inc.
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 