<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/NCT01718886</url>
  </required_header>
  <id_info>
    <org_study_id>PTL-1000-0018</org_study_id>
    <nct_id>NCT01718886</nct_id>
  </id_info>
  <brief_title>European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss</brief_title>
  <official_title>Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss</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>
      The objective of this study is to evaluate the initial safety and preliminary effectiveness&#xD;
      of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27&#xD;
      - 35 kg/m^2&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Excess Weight Loss based on an ideal BMI of 25.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of all adverse events.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Control</condition>
  <arm_group>
    <arm_group_label>Obalon Gastric Balloon</arm_group_label>
    <description>Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Obalon Gastric Balloon</intervention_name>
    <arm_group_label>Obalon Gastric Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were selected from investigators' patient population and included patients with a&#xD;
        BMI in the range of 27 - 35 kg/m^2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Were between 21-64 years of age;&#xD;
&#xD;
          -  Had a BMI 27-35 Kg/cm&#xD;
&#xD;
          -  Did not have a history of weight reduction over 5% of body weight over the past 6&#xD;
             months&#xD;
&#xD;
          -  Were able to comply with all study requirements for the duration of the study as&#xD;
             outlined in the protocol. This included complying with the visit schedule as well as&#xD;
             study specific procedures such as: electrocardiography, endoscopy, upper&#xD;
             gastrointestinal radiography and clinical lab testing&#xD;
&#xD;
          -  Were able to understand and willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Experienced any difficulty in swallowing;&#xD;
&#xD;
          -  Had unstable angina, myocardial infarction within the past year, or heart disease&#xD;
             classified within the New York Heart Association's Class III or IV functional&#xD;
             capacity;&#xD;
&#xD;
          -  Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other&#xD;
             medications known to be gastric irritants, and not willingness to discontinue the use&#xD;
             of these concomitant medications, antiarrythmics, anti-anginal medications,&#xD;
             anticoagulants or medications for congestive heart failure;&#xD;
&#xD;
          -  Taking blood pressure medications, unless their blood pressure was controlled and they&#xD;
             have been at stable dose for at least 3 months;&#xD;
&#xD;
          -  Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;&#xD;
&#xD;
          -  Had a history or symptoms of thyroid disease which is not controlled by medication;&#xD;
&#xD;
          -  Had severe renal, hepatic, pulmonary disease or cancer;&#xD;
&#xD;
          -  Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy);&#xD;
&#xD;
          -  Had any abnormal stenosis or obstruction of the GI tract;&#xD;
&#xD;
          -  Had a history of adhesive peritonitis;&#xD;
&#xD;
          -  Had a previously diagnosed hiatal hernia greater than 2cm;&#xD;
&#xD;
          -  Had any abnormality of the esophagus, stomach or pylorus;&#xD;
&#xD;
          -  Had history of severe esophagitis;&#xD;
&#xD;
          -  Had history or symptoms of esophageal and/or gastric varices;&#xD;
&#xD;
          -  Had history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or&#xD;
             diverticula);&#xD;
&#xD;
          -  Had history or symptoms of inflammatory bowel disease, such as Chron's disease;&#xD;
&#xD;
          -  Had history of/ signs and /or symptoms of duodenal or gastric ulcer;&#xD;
&#xD;
          -  Untreated H.Pylori&#xD;
&#xD;
          -  Had history or signs of dysphasia, achalasia or symptoms of or GI motility;&#xD;
&#xD;
          -  Were undergoing chronic steroid or immunosuppressive therapy;&#xD;
&#xD;
          -  Were pregnant or breastfeeding or had the intention of becoming pregnant during the&#xD;
             study;&#xD;
&#xD;
          -  Had placement of previous intragastric balloon or similar device;&#xD;
&#xD;
          -  Were using pharmaceutical agents for weight loss;&#xD;
&#xD;
          -  Were drinking alcohol in excess or using illicit drugs;&#xD;
&#xD;
          -  Had bulimia or binge eating disorders;&#xD;
&#xD;
          -  Had impending gastric surgery 30 days post balloon removal;&#xD;
&#xD;
          -  Had planned flying or scuba diving activities during balloon residence time;&#xD;
&#xD;
          -  Had any other condition that, in the opinion of the investigator, would interfere with&#xD;
             their participation and compliance with the study (i.e. psychosocial issues);&#xD;
&#xD;
          -  Were participating in other investigational study protocols. If a subject had recently&#xD;
             completed participation in another drug or device study, the subject must have&#xD;
             completed that study at least 30 days prior to being enrolled in this study;&#xD;
&#xD;
          -  Had history or known allergies to any component of the device materials, including but&#xD;
             not limited to allergies to porcine proteins.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fancois Mion, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Edouard Harriot</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Deviere</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasme hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology, Erasme Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>6B1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service D'exploration Functionelle Digestive, Hospital Edouard Harriot</name>
      <address>
        <city>Lyon</city>
        <state>Cedex</state>
        <zip>69473</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.obalon.com</url>
    <description>Sponsor's website</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Weight control</keyword>
  <keyword>Intragastric balloon</keyword>
  <keyword>gastric balloon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01718886
org study id: PTL-1000-0018
nct id: NCT01718886
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the initial safety and preliminary effectiveness
      of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27
      - 35 kg/m^2
observational model: Cohort
time perspective: Prospective
measure: Percent Excess Weight Loss based on an ideal BMI of 25.
time frame: 12 weeks
measure: Assessment of all adverse events.
time frame: 12 weeks
arm group label: Obalon Gastric Balloon
description: Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks
intervention type: Device
intervention name: Obalon Gastric Balloon
arm group label: Obalon Gastric Balloon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: No
last name: Fancois Mion, MD
role: Principal Investigator
affiliation: Hospital Edouard Harriot
last name: Jacques Deviere
role: Principal Investigator
affiliation: Erasme hospital
facility: 
facility: 
country: Belgium
country: France
url: http://www.obalon.com
description: Sponsor's website
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss