<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/NCT03233048</url>
  </required_header>
  <id_info>
    <org_study_id>15-009191</org_study_id>
    <nct_id>NCT03233048</nct_id>
  </id_info>
  <brief_title>Intragastric Balloon in Obese Adolescents With Comorbidities</brief_title>
  <acronym>IGB</acronym>
  <official_title>Safety and Efficacy of Endoscopically Placed Intragastric Balloon in Obese Adolescents With Comorbidities - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imad Absah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reason we are doing this research is to get information about the ORBERA™ Intragastric&#xD;
      Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are&#xD;
      overweight will lose weight and if their other medical problems will get better. ORBERA™ is a&#xD;
      special balloon approved by the FDA for overweight adults, and we would like to try using it&#xD;
      for overweight teenagers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining consent and determining that participants meet the inclusion and exclusion&#xD;
      criteria, participants will have baseline tests and initial visits with a physician,&#xD;
      dietitian, and psychologist. Next, the ORBERA™ Intragastric Balloon (IGB) will be inserted&#xD;
      into the stomach and then removed after 6 months. Participants will continue to be followed&#xD;
      for 6 months after the balloon is removed. Throughout the year, participants will have&#xD;
      additional tests along with ongoing visits with a physician, dietitian, and psychologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Weight loss will be measured by change in weight divided by baseline weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Alanine Aminotransferase (ALT)</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in ALT divided by baseline ALT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aspartate Aminotransferase (AST)</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in AST divided by baseline AST.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Insulin</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hemoglobin A1c (HgA1c)</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High-density Lipoprotein (HDL)</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in HDL divided by baseline HDL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low-density Lipoprotein (LDL)</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in LDL divided by baseline LDL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides</measure>
    <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
    <description>Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With One or More Serious Adverse Events</measure>
    <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
    <description>Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Had the Balloon Removed Early</measure>
    <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
    <description>Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Whose Balloon Deflated Early</measure>
    <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
    <description>Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>ORBERA™ Intragastric Balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ORBERA™ Intragastric Balloon</intervention_name>
    <description>The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
    <arm_group_label>ORBERA™ Intragastric Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI&gt;35 kilogram per square meter (kg/m2) with one of the following severe comorbidities,&#xD;
        both for at least 2 years:&#xD;
&#xD;
          1. Type 2 diabetes mellitus&#xD;
&#xD;
          2. Moderate-to-severe sleep apnea&#xD;
&#xD;
          3. Pseudotumor cerebri&#xD;
&#xD;
          4. Nonalcoholic Steatohepatitis (NASH) based on fatty infiltration of the liver with&#xD;
             transaminitis that cannot be explained by other liver disease&#xD;
&#xD;
        Or,&#xD;
&#xD;
        BMI&gt;40 kilogram per square meter (kg/m2) with two or more of the following mild&#xD;
        comorbidities, all for at least 2 years:&#xD;
&#xD;
          1. Hypertension&#xD;
&#xD;
          2. Dyslipidemia&#xD;
&#xD;
          3. Mild obstructive sleep apnea&#xD;
&#xD;
          4. Chronic venous insufficiency&#xD;
&#xD;
          5. Panniculitis&#xD;
&#xD;
          6. Urinary incontinence&#xD;
&#xD;
          7. Nonalcoholic Steatohepatitis (NASH)&#xD;
&#xD;
          8. Gastroesophageal reflux disease (GERD)&#xD;
&#xD;
          9. Arthropathies related to weight&#xD;
&#xD;
        In addition, all of the following inclusion criteria must be met. The subject must have:&#xD;
&#xD;
          1. attained approximately 95% of adult stature, as demonstrated by Tanner Stage IV or&#xD;
             more and growth charts demonstrating the taper/plateau of height as a marker for&#xD;
             achieving 95% of the subject's adult stature. Height will be measured by trained staff&#xD;
             to the nearest 0.1 cm using a stadiometer attached to a wall and documented in the&#xD;
             subject's electronic medical record (EMR). In the absence of previous growth charts,&#xD;
             skeletal maturity will be documented by a bone age of at least 13 years in girls and&#xD;
             15 years in boys; and&#xD;
&#xD;
          2. failed to attain a healthy weight with at least one experience with medically&#xD;
             supervised lifestyle changes, including physical activity and dietary interventions,&#xD;
             which will be clearly documented in the subject's medical record, and&#xD;
&#xD;
          3. demonstrated commitment to psychological evaluation perioperatively, in which the&#xD;
             pediatric psychologist with expertise in childhood obesity must confirm that the&#xD;
             subject has the maturity and stable psychosocial environment necessary for this&#xD;
             research study and has validated the Center for Epidemiology Study Depression (CES-D)&#xD;
             scale and Spence Children's Anxiety Scale (SCAS) surveys completed by the subject, and&#xD;
&#xD;
          4. agreed to avoid pregnancy for 1 year after intragastric balloon (IGB) placement&#xD;
             through abstinence or approved contraception (female subjects only), and&#xD;
&#xD;
          5. agreed to adhere to nutritional guidelines after intragastric balloon (IGB) placement,&#xD;
             as provided by weight management clinic dietitian, and&#xD;
&#xD;
          6. decisional capacity and desire to provide informed assent in conjunction with&#xD;
             parent/guardian consent, and willingness to comply with all study requirements, and&#xD;
&#xD;
          7. hypertension stage I: systolic blood pressure and/or diastolic blood pressure ≥ 95th&#xD;
             percentile, OR high normal blood pressure between the 90th and 95th percentile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if:&#xD;
&#xD;
          1. they are pregnant or breastfeeding, or&#xD;
&#xD;
          2. there is any other disease, physical examination finding, or clinical laboratory&#xD;
             result that provides a reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of the investigational device or that may affect the&#xD;
             interpretation of the results or render the subject at high risk for treatment&#xD;
             complications, or&#xD;
&#xD;
          3. there is alcohol, tobacco, or substance use by the subject, or&#xD;
&#xD;
          4. in the opinion of the principal investigator (PI) and/or co-investigators, subject or&#xD;
             parent/guardian may be non-compliant with study schedules or procedures, or&#xD;
&#xD;
          5. there are any endoscopic contraindications, including large hiatal hernia (≥ 2 cm),&#xD;
             esophagitis of any degree, erosive gastritis, or ulceration of the stomach or&#xD;
             duodenum, or&#xD;
&#xD;
          6. Helicobacter pylori (H. pylori) is detected via a fecal antigen study prior to initial&#xD;
             endoscopic assessment (sensitivity &gt; 96.8%); once treated, a repeat fecal antigen must&#xD;
             be performed to document eradication prior to the first endoscopic approach for&#xD;
             balloon placement, or&#xD;
&#xD;
          7. they have hypertension stage II &gt; 99th percentile, unless they had a complete workup&#xD;
             to exclude secondary etiologies other than being overweight, or&#xD;
&#xD;
          8. Gastroesophageal reflux disease (GERD) subjects are on more than one medication or&#xD;
             have a history of erosive esophagitis due to gastroesophageal reflux disease (GERD),&#xD;
             or&#xD;
&#xD;
          9. they have dyslipidemia, if part of hereditary metabolic syndrome or genetic disorder,&#xD;
             or&#xD;
&#xD;
         10. they have any gastrointestinal disease that can result in stomach ulcerations, such as&#xD;
             Crohn's disease, celiac disease, eosinophilic esophagitis, acute or chronic&#xD;
             pancreatitis or gastrinoma, or&#xD;
&#xD;
         11. they have any endocrine disorders that affect metabolic status of the subjects, such&#xD;
             as hypo/hyperthyroidism, type 1 diabetes, Cushing's disease, or adrenal insufficiency,&#xD;
             as documented in the electronic medical record (EMR) through an evaluation by the&#xD;
             pediatric endocrinologist who will order additional testing if needed, or&#xD;
&#xD;
         12. they have prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or&#xD;
             adhesive peritonitis or known abdominal adhesions and/or history of abdominal and/or&#xD;
             pelvic surgery which may cause adhesions (except one of the following: caesarean&#xD;
             section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic&#xD;
             cholecystectomy performed 12 or more months prior to balloon implantation), or&#xD;
&#xD;
         13. they have prior open or laparoscopic bariatric surgery, or&#xD;
&#xD;
         14. they have prior surgery of any kind on the esophagus, stomach or any type of hiatal&#xD;
             hernia surgery, or&#xD;
&#xD;
         15. they have any inflammatory disease of the gastrointestinal tract including&#xD;
             esophagitis, Barrett's esophagus, cancer or specific inflammation such as Crohn's&#xD;
             disease, or&#xD;
&#xD;
         16. they have potential upper gastrointestinal bleeding conditions such as esophageal or&#xD;
             gastric varices, congenital or acquired intestinal telangiectasis, or other congenital&#xD;
             anomalies of the gastrointestinal tract such as atresias or stenoses, or,&#xD;
&#xD;
         17. they have a gastric mass, or&#xD;
&#xD;
         18. they have acid reflux symptoms to any degree that require more than one medication for&#xD;
             symptom control, or&#xD;
&#xD;
         19. they have a structural abnormality in the esophagus or pharynx such as a stricture or&#xD;
             diverticulum that could impede passage of the balloon alongside the endoscope, or&#xD;
&#xD;
         20. they have achalasia or any other severe esophageal motility disorder that may pose a&#xD;
             safety risk during the removal of the device, or&#xD;
&#xD;
         21. they have severe coagulopathy, or&#xD;
&#xD;
         22. they have poorly controlled diabetes, defined as having a Hemoglobin A1c (HgA1c) &gt; 10,&#xD;
             or&#xD;
&#xD;
         23. they have serious health conditions unrelated to their weight that would increase the&#xD;
             risk of endoscopy, or&#xD;
&#xD;
         24. they have chronic abdominal pain, or&#xD;
&#xD;
         25. they have motility disorders of the gastrointestinal (GI) tract such as gross&#xD;
             esophageal motility disorders, gastroparesis, or intractable constipation, or&#xD;
&#xD;
         26. they have hepatic insufficiency or cirrhosis, or&#xD;
&#xD;
         27. they have serious or uncontrolled psychiatric illness or disorder that could&#xD;
             compromise their understanding of, or compliance with, follow-up visits and removal of&#xD;
             the device, or&#xD;
&#xD;
         28. they are receiving daily prescribed treatment with aspirin, anti-inflammatory agents,&#xD;
             anticoagulants or other gastric irritants, or&#xD;
&#xD;
         29. they are taking medications on specified hourly intervals that may be affected by&#xD;
             changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications, or&#xD;
&#xD;
         30. they are taking corticosteroids, immunosuppressants, or narcotics, or&#xD;
&#xD;
         31. they are unable or unwilling to take prescribed proton pump inhibitor medication, or&#xD;
&#xD;
         32. they are known to have, or suspected to have, an allergic reaction to materials&#xD;
             contained in the system, or&#xD;
&#xD;
         33. they have ever developed a serotonin syndrome and are currently taking any drug known&#xD;
             to affect the levels of serotonin in the body (e.g. selective serotonin reuptake&#xD;
             inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase&#xD;
             inhibitors), or&#xD;
&#xD;
         34. they have a medically identifiable cause of obesity (specific diagnosed genetic or&#xD;
             hormonal case for obesity such as hypothyroidism or Prader Willi syndrome), or&#xD;
&#xD;
         35. they have known history of endocrine disorders affecting weight, or&#xD;
&#xD;
         36. they use any medications, except for Metformin, known to affect body weight and&#xD;
             carbohydrate or lipid metabolism, or&#xD;
&#xD;
         37. they used an intragastric device prior to this study, or&#xD;
&#xD;
         38. they participated in any clinical study which could affect weight loss within the past&#xD;
             6 months, or&#xD;
&#xD;
         39. they have symptomatic congestive heart failure or cardiac arrhythmia, or&#xD;
&#xD;
         40. they have a diagnosis of an autoimmune connective tissue disorder (e.g. lupus,&#xD;
             erythematous, scleroderma), or immunocompromised, or&#xD;
&#xD;
         41. they are on insulin for type 2 diabetes and not proficient in self-monitoring&#xD;
             capillary blood glucose testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Imad Absah, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>February 25, 2022</results_first_submitted>
  <results_first_submitted_qc>April 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2022</results_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Imad Absah</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03233048/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ORBERA™ Intragastric Balloon</title>
          <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ORBERA™ Intragastric Balloon</title>
          <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </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="16" spread="0.7"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss</title>
        <description>Weight loss will be measured by change in weight divided by baseline weight.</description>
        <time_frame>up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss</title>
          <description>Weight loss will be measured by change in weight divided by baseline weight.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Alanine Aminotransferase (ALT)</title>
        <description>Change will be measured as a percentage by taking change in ALT divided by baseline ALT.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Alanine Aminotransferase (ALT)</title>
          <description>Change will be measured as a percentage by taking change in ALT divided by baseline ALT.</description>
          <units>percentage of change in ALT level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Aspartate Aminotransferase (AST)</title>
        <description>Change will be measured as a percentage by taking change in AST divided by baseline AST.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aspartate Aminotransferase (AST)</title>
          <description>Change will be measured as a percentage by taking change in AST divided by baseline AST.</description>
          <units>percentage of change in AST level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Insulin</title>
        <description>Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Insulin</title>
          <description>Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.</description>
          <units>percentage of change in insulin level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hemoglobin A1c (HgA1c)</title>
        <description>Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hemoglobin A1c (HgA1c)</title>
          <description>Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.</description>
          <units>percentage of change in HgA1c level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in High-density Lipoprotein (HDL)</title>
        <description>Change will be measured as a percentage by taking change in HDL divided by baseline HDL.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in High-density Lipoprotein (HDL)</title>
          <description>Change will be measured as a percentage by taking change in HDL divided by baseline HDL.</description>
          <units>percentage of change in HDL level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Low-density Lipoprotein (LDL)</title>
        <description>Change will be measured as a percentage by taking change in LDL divided by baseline LDL.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Low-density Lipoprotein (LDL)</title>
          <description>Change will be measured as a percentage by taking change in LDL divided by baseline LDL.</description>
          <units>percentage of change in LDL level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides</title>
        <description>Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.</description>
        <time_frame>Baseline, end of study (approximately 1 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides</title>
          <description>Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.</description>
          <units>percentage of change in triglycerides</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With One or More Serious Adverse Events</title>
        <description>Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.</description>
        <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Serious Adverse Events</title>
          <description>Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Had the Balloon Removed Early</title>
        <description>Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.</description>
        <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
        <population>At the request of the subject Intragastric balloon (IGB) was removed at 3 months and the subject was withdrawn from the study (withdrawal by subject).</population>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Had the Balloon Removed Early</title>
          <description>Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.</description>
          <population>At the request of the subject Intragastric balloon (IGB) was removed at 3 months and the subject was withdrawn from the study (withdrawal by subject).</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Whose Balloon Deflated Early</title>
        <description>Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.</description>
        <time_frame>Intragastric balloon (IGB) removal (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ORBERA™ Intragastric Balloon</title>
            <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Whose Balloon Deflated Early</title>
          <description>Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study participation for a total of approximately 12 months on all participants</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ORBERA™ Intragastric Balloon</title>
          <description>Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.&#xD;
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="4" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Abdominal pain/discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT 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>Dr. Imad Absah</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-266-0114</phone>
      <email>absah.imad@mayo.edu</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/NCT03233048
org study id: 15-009191
nct id: NCT03233048
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The reason we are doing this research is to get information about the ORBERA™ Intragastric
      Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are
      overweight will lose weight and if their other medical problems will get better. ORBERA™ is a
      special balloon approved by the FDA for overweight adults, and we would like to try using it
      for overweight teenagers.
After obtaining consent and determining that participants meet the inclusion and exclusion
      criteria, participants will have baseline tests and initial visits with a physician,
      dietitian, and psychologist. Next, the ORBERA™ Intragastric Balloon (IGB) will be inserted
      into the stomach and then removed after 6 months. Participants will continue to be followed
      for 6 months after the balloon is removed. Throughout the year, participants will have
      additional tests along with ongoing visits with a physician, dietitian, and psychologist.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss
time frame: up to 1 year
description: Weight loss will be measured by change in weight divided by baseline weight.
measure: Change in Alanine Aminotransferase (ALT)
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in ALT divided by baseline ALT.
measure: Change in Aspartate Aminotransferase (AST)
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in AST divided by baseline AST.
measure: Change in Fasting Insulin
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.
measure: Change in Hemoglobin A1c (HgA1c)
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.
measure: Change in High-density Lipoprotein (HDL)
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in HDL divided by baseline HDL.
measure: Change in Low-density Lipoprotein (LDL)
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in LDL divided by baseline LDL.
measure: Change in Triglycerides
time frame: Baseline, end of study (approximately 1 year)
description: Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.
measure: Number of Participants With One or More Serious Adverse Events
time frame: Intragastric balloon (IGB) removal (approximately 6 months)
description: Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.
measure: Number of Subjects Who Had the Balloon Removed Early
time frame: Intragastric balloon (IGB) removal (approximately 6 months)
description: Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.
measure: Number of Subjects Whose Balloon Deflated Early
time frame: Intragastric balloon (IGB) removal (approximately 6 months)
description: Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.
arm group label: ORBERA™ Intragastric Balloon
arm group type: Experimental
description: Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
intervention type: Device
intervention name: ORBERA™ Intragastric Balloon
description: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
arm group label: ORBERA™ Intragastric Balloon
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: No
last name: Imad Absah, M.D.
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Imad Absah
investigator title: Assistant Professor of Pediatrics
sharing ipd: No
provided document: 
participant flow: 
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reported events: 
certain agreements: 
point of contact: 