<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/NCT03760861</url>
  </required_header>
  <id_info>
    <org_study_id>2018/00018</org_study_id>
    <nct_id>NCT03760861</nct_id>
  </id_info>
  <brief_title>First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule</brief_title>
  <official_title>First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanyang Technological University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the ease of deployment of a novel&#xD;
      magnetically-controlled ingestible weight loss microcapsule* and the functionality of the&#xD;
      magnetically controlled inflation of the balloon within the stomach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to demonstrate the ease of deployment of a novel&#xD;
      magnetically-controlled ingestible weight loss microcapsule and the functionality of the&#xD;
      magnetically controlled inflation of the balloon within the stomach. Device comes in the form&#xD;
      of a gelatine coated pill (Ø9.6mm x 27mm) . Once in the stomach, the device may be driven by&#xD;
      external magnetic controllers which can control both its position and orientation. It allows&#xD;
      flexible approach of the external magnetic fields in any axial directions of the device, and&#xD;
      it also controls the inflation valve which controls the inflation of an attached balloon. The&#xD;
      inflated balloon will partially fill up the stomach, giving the subject the feel of satiety&#xD;
      to reduce his/her desire to eat more food.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <intervention_model_description>Open label pilot study</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful inflation and maintenance of the fully inflated intragastric balloon.</measure>
    <time_frame>10 minutes</time_frame>
    <description>A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">3</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Prototype Microcapsule Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention by placement of prototype weight-loss microcapsule in the stomach. Subjects will have a weight-loss microcapsule deployed endoscpically in the stomach. The intragastric balloon in the capsule will be inflated using an external magnet..</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype Microcapsule Treatment</intervention_name>
    <description>The subject will be sedated and using an endoscope, a prototype microcapsule will be placed into the gastric corpus. Then, an external handheld magnet will be applied to inflate the balloon encapsulated in the microcapsule. Upon ascertaining the full inflation based on the endoscopic visualization, the investigator will wait another 10 minutes after that to observe how the subject feels before manually puncturing the balloon with needle knife, and retrieving the punctured balloon with the RothNet through the mouth.</description>
    <arm_group_label>Prototype Microcapsule Treatment Arm</arm_group_label>
    <other_name>Prototype weight-loss microcapsule placement in stomach</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Healthy subject, as evidenced by medical history&#xD;
&#xD;
          -  Male or female aged 21-50 years of age&#xD;
&#xD;
          -  Willing to undergo endoscopy to retrieve the balloon and to comply with all study&#xD;
             procedures&#xD;
&#xD;
          -  Ability to provide a signed and dated informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with anatomical abnormalities or functional disorders that may inhibit&#xD;
             swallowing or passage through to the stomach&#xD;
&#xD;
          -  Individuals with history or symptoms of clinically significant esophageal or gastric&#xD;
             disorders, peptic ulcerations, hiatal hernia, patulous pyloric channel, erosive&#xD;
             esophagitis, varices, angiectasia, Barrett's esophagus&#xD;
&#xD;
          -  Individuals with bowel obstruction, congenital or acquired GI anomalies (e.g.,&#xD;
             atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or&#xD;
             pulmonary disease&#xD;
&#xD;
          -  Individuals with bleeding disorders&#xD;
&#xD;
          -  Individuals already having other bioenteric devices placed&#xD;
&#xD;
          -  Individuals who have pace makers, metal implants or other devices on them&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Individuals unable to make/sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khek Yu Ho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Khek Yu Ho, MD</last_name>
    <phone>65 67795555</phone>
    <email>khek_yu_ho@nuhs.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khek Yu Ho, MD</last_name>
      <phone>65 67795555</phone>
      <email>khek_yu_ho@nuhs.edu.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>April 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</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>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03760861
org study id: 2018/00018
nct id: NCT03760861
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this study is to demonstrate the ease of deployment of a novel
      magnetically-controlled ingestible weight loss microcapsule* and the functionality of the
      magnetically controlled inflation of the balloon within the stomach.
The objective of this study is to demonstrate the ease of deployment of a novel
      magnetically-controlled ingestible weight loss microcapsule and the functionality of the
      magnetically controlled inflation of the balloon within the stomach. Device comes in the form
      of a gelatine coated pill (Ø9.6mm x 27mm) . Once in the stomach, the device may be driven by
      external magnetic controllers which can control both its position and orientation. It allows
      flexible approach of the external magnetic fields in any axial directions of the device, and
      it also controls the inflation valve which controls the inflation of an attached balloon. The
      inflated balloon will partially fill up the stomach, giving the subject the feel of satiety
      to reduce his/her desire to eat more food.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label pilot study
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Successful inflation and maintenance of the fully inflated intragastric balloon.
time frame: 10 minutes
description: A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.
arm group label: Prototype Microcapsule Treatment Arm
arm group type: Experimental
description: Intervention by placement of prototype weight-loss microcapsule in the stomach. Subjects will have a weight-loss microcapsule deployed endoscpically in the stomach. The intragastric balloon in the capsule will be inflated using an external magnet..
intervention type: Device
intervention name: Prototype Microcapsule Treatment
description: The subject will be sedated and using an endoscope, a prototype microcapsule will be placed into the gastric corpus. Then, an external handheld magnet will be applied to inflate the balloon encapsulated in the microcapsule. Upon ascertaining the full inflation based on the endoscopic visualization, the investigator will wait another 10 minutes after that to observe how the subject feels before manually puncturing the balloon with needle knife, and retrieving the punctured balloon with the RothNet through the mouth.
arm group label: Prototype Microcapsule Treatment Arm
other name: Prototype weight-loss microcapsule placement in stomach
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khek Yu Ho, MD
role: Principal Investigator
affiliation: National University Health System
last name: Khek Yu Ho, MD
phone: 65 67795555
email: khek_yu_ho@nuhs.edu.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No