<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/NCT03239821</url>
  </required_header>
  <id_info>
    <org_study_id>S60320</org_study_id>
    <nct_id>NCT03239821</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the VIPUN Balloon Catheter 0.1</brief_title>
  <acronym>ANTERO-1</acronym>
  <official_title>ANTERO-1: a Clinical Evaluation of an Investigational Device: the VIPUN Balloon Catheter 0.1 Used for the Evaluation of Gastric Motility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this investigation is to assess the safety, feasibility and performance of&#xD;
      the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will&#xD;
      also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric&#xD;
      motility and emptying. Furthermore, this investigation will examine whether gastric motility&#xD;
      and emptying as measured in this study are correlated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 27, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.</measure>
    <time_frame>8 hours</time_frame>
    <description>Incidence, frequency, severity, seriousness and relatedness of AEs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.</measure>
    <time_frame>8 hours</time_frame>
    <description>Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.</measure>
    <time_frame>8 hours</time_frame>
    <description>Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon</measure>
    <time_frame>8 hours</time_frame>
    <description>To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)</measure>
    <time_frame>8 hours</time_frame>
    <description>To explore whether there is a correlation between gastric motility and emptying.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <condition>Motility Disorder</condition>
  <condition>Gastric Emptying</condition>
  <arm_group>
    <arm_group_label>Placebo - deflated balloon</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - inflated balloon</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Codeine - delfated balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Codeine - inflated balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VIPUN Balloon Catheter 0.1 deflated</intervention_name>
    <description>deflation balloon</description>
    <arm_group_label>Codeine - delfated balloon</arm_group_label>
    <arm_group_label>Placebo - deflated balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Codeine Phosphate</intervention_name>
    <description>58.8 mg codeïne phosphate</description>
    <arm_group_label>Codeine - delfated balloon</arm_group_label>
    <arm_group_label>Codeine - inflated balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sirupus Simplex</description>
    <arm_group_label>Placebo - deflated balloon</arm_group_label>
    <arm_group_label>Placebo - inflated balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VIPUN Balloon Catheter 0.1 inflated</intervention_name>
    <description>VIPUN Balloon Catheter 0.1 inflated</description>
    <arm_group_label>Codeine - inflated balloon</arm_group_label>
    <arm_group_label>Placebo - inflated balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  Aged between and including 18 and 65 years&#xD;
&#xD;
          -  BMI between and including 18 and 25&#xD;
&#xD;
          -  Understand and able to read Dutch&#xD;
&#xD;
          -  In good health on the basis of medical history&#xD;
&#xD;
          -  Able to return home without driving a vehicle on visit days 1-4&#xD;
&#xD;
          -  Will not operate machines on the same day of treatment (visits 1-4)&#xD;
&#xD;
          -  Females subjects of childbearing potential are willing to use adequate contraception&#xD;
&#xD;
          -  Refrains from herbal, vitamin and other dietary supplements on the day of the visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria related to possible influence on end-points:&#xD;
&#xD;
          -  Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)&#xD;
&#xD;
          -  Using any medication that might affect gastric function or visceral sensitivity&#xD;
&#xD;
          -  Known / suspected current use of illicit drugs&#xD;
&#xD;
          -  Known psychiatric or neurological illness&#xD;
&#xD;
          -  Any gastrointestinal surgery that could influence normal gastric function in the&#xD;
             opinion of the investigator&#xD;
&#xD;
        Exclusion criteria related to positioning of the catheter:&#xD;
&#xD;
          -  History of heart or vascular diseases like irregular heartbeats, angina or heart&#xD;
             attack&#xD;
&#xD;
          -  Nasopharyngeal, upper GI or esophageal surgery in the last 30 days&#xD;
&#xD;
          -  Suspected basal skull fracture or severe maxillofacial trauma&#xD;
&#xD;
          -  History of thermal or chemical injury to upper respiratory tract or esophagus&#xD;
&#xD;
          -  Current esophageal or nasopharyngeal obstruction&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
          -  Known esophageal varices&#xD;
&#xD;
        Exclusion criteria related to codeine administration:&#xD;
&#xD;
          -  History of opioid dependency&#xD;
&#xD;
          -  Known severely decreased kidney or liver function&#xD;
&#xD;
          -  Pregnant or breastfeeding women (pregnancy test will be performed on females with&#xD;
             childbearing potential)&#xD;
&#xD;
          -  Known severe lung disease (e.g. asthma or emphysema)&#xD;
&#xD;
          -  Have known side-effects/allergic reactions when taking codeine/morphine&#xD;
&#xD;
          -  Known diabetic, fructose intolerance or malabsorption of glucose or galactose or&#xD;
             sucrose-isomalase insufficiency.&#xD;
&#xD;
        Exclusion criteria related to Sirupus simplex administration:&#xD;
&#xD;
        • Known diabetic (saccharose), intolerance to or malabsorption of propylene glycol and&#xD;
        methyl- and propylparahydroxybenzoate&#xD;
&#xD;
        Exclusion criteria related to nutrients (Fortimel):&#xD;
&#xD;
        • Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient&#xD;
        of Fortimel Energy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Codeine</mesh_term>
  </intervention_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/NCT03239821
org study id: S60320
nct id: NCT03239821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary aim of this investigation is to assess the safety, feasibility and performance of
      the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will
      also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric
      motility and emptying. Furthermore, this investigation will examine whether gastric motility
      and emptying as measured in this study are correlated.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Safety: Incidence, frequency, severity, seriousness and relatedness of AEs during the 8 hour visit.
time frame: 8 hours
description: Incidence, frequency, severity, seriousness and relatedness of AEs
measure: Feasibility: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter) during the 8 hour visit.
time frame: 8 hours
description: Success rate in completing the procedure (placement and removal VIPUN Balloon Catheter)
measure: Performance: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon) during the 8 hour visit.
time frame: 8 hours
description: Motility index (MI) decrease after codeine treatment vs. placebo treatment (inflated balloon)
measure: Change in gastric emptying: placebo vs. codeine and deflated vs. inflated balloon
time frame: 8 hours
description: To explore whether the VIPUN Balloon Catheter 0.1 can influence gastric motility and/or emptying.
measure: Correlation motility index change and gastric emptying time change: placebo vs. codeine (inflated balloon)
time frame: 8 hours
description: To explore whether there is a correlation between gastric motility and emptying.
arm group label: Placebo - deflated balloon
arm group type: Sham Comparator
arm group label: Placebo - inflated balloon
arm group type: Placebo Comparator
arm group label: Codeine - delfated balloon
arm group type: Active Comparator
arm group label: Codeine - inflated balloon
arm group type: Active Comparator
intervention type: Device
intervention name: VIPUN Balloon Catheter 0.1 deflated
description: deflation balloon
arm group label: Codeine - delfated balloon
arm group label: Placebo - deflated balloon
intervention type: Drug
intervention name: Codeine Phosphate
description: 58.8 mg codeïne phosphate
arm group label: Codeine - delfated balloon
arm group label: Codeine - inflated balloon
intervention type: Drug
intervention name: Placebo
description: Sirupus Simplex
arm group label: Placebo - deflated balloon
arm group label: Placebo - inflated balloon
intervention type: Device
intervention name: VIPUN Balloon Catheter 0.1 inflated
description: VIPUN Balloon Catheter 0.1 inflated
arm group label: Codeine - inflated balloon
arm group label: Placebo - inflated balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Codeine