<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/NCT04485936</url>
  </required_header>
  <id_info>
    <org_study_id>PRT-05-030</org_study_id>
    <nct_id>NCT04485936</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects</brief_title>
  <official_title>Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epitomee medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Epitomee medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be enrolled in one investigational site. Subjects meeting eligibility&#xD;
      criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment&#xD;
      (baseline).&#xD;
&#xD;
      Following the scintigraphy, the subjects will receive Tulip Device treatment - 2&#xD;
      capsules/day.&#xD;
&#xD;
      After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo&#xD;
      additional gastric emptying test with a capsule intake prior to the test meal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Actual">July 9, 2019</completion_date>
  <primary_completion_date type="Actual">April 9, 2019</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>Evaluation of Epitomee device on Gastric half-emptying time</measure>
    <time_frame>10 days</time_frame>
    <description>Change in Gastric half-emptying time</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Epitomee Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Epitomee Device</intervention_name>
    <description>medical Device designed to enhance the feeling of early satiation and prolonged satiety</description>
    <arm_group_label>Epitomee Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 21 ≤ Age &lt;65 years&#xD;
&#xD;
          2. 20 &lt; BMI ≤ 40 kg/m2&#xD;
&#xD;
          3. Healthy subject&#xD;
&#xD;
          4. Subject is able and willing to give informed consent&#xD;
&#xD;
          5. Subject is able and willing to participate in the study and follow protocol procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant swallowing disorders or difficulty swallowing&#xD;
&#xD;
          2. Suspected GI strictures, fistulas or other GI track obstructions&#xD;
&#xD;
          3. Crohn's disease or diverticulosis&#xD;
&#xD;
          4. Recent GI surgery&#xD;
&#xD;
          5. History of long-standing undigested food in the stomach&#xD;
&#xD;
          6. Known ulcer disease&#xD;
&#xD;
          7. Organic disease associated with gastroparesis such a Parkinson's disease,&#xD;
             cerebrovascular accident, neuromuscular disease or eating disorder&#xD;
&#xD;
          8. Presence of a gastrostomy tube or gastric outlet obstruction&#xD;
&#xD;
          9. History or evidence of any active liver disease&#xD;
&#xD;
         10. Allergy to eggs&#xD;
&#xD;
         11. Treatment with anticholinergic or prokinetic agents&#xD;
&#xD;
         12. Treatment with proton-pump inhibitors&#xD;
&#xD;
         13. Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as&#xD;
             L-thyroxine)&#xD;
&#xD;
         14. Prediabetes or Diabetes&#xD;
&#xD;
         15. Any history or evidence of significant cardiac, renal, neurologic, pulmonary,&#xD;
             gastrointestinal, hematologic abnormality, chronic hepatic disease or any other&#xD;
             disease or symptom which in the judgment of the investigator would interfere with the&#xD;
             study or confound the results&#xD;
&#xD;
         16. Pregnancy or breastfeeding&#xD;
&#xD;
         17. Currently participating in an ongoing clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haim Shirin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2018</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participants data for all primary and secondary outcome measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be available within six months of study completion</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04485936
org study id: PRT-05-030
nct id: NCT04485936
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
The participants will be enrolled in one investigational site. Subjects meeting eligibility
      criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment
      (baseline).

      Following the scintigraphy, the subjects will receive Tulip Device treatment - 2
      capsules/day.

      After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo
      additional gastric emptying test with a capsule intake prior to the test meal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of Epitomee device on Gastric half-emptying time
time frame: 10 days
description: Change in Gastric half-emptying time
arm group label: Epitomee Device
arm group type: Experimental
description: the participants receive the device which is non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of early satiation and prolonged satiety
intervention type: Device
intervention name: Epitomee Device
description: medical Device designed to enhance the feeling of early satiation and prolonged satiety
arm group label: Epitomee Device
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haim Shirin, MD
role: Principal Investigator
affiliation: The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: Yes
ipd description: De-identified individual participants data for all primary and secondary outcome measures will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be available within six months of study completion