<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/NCT03778697</url>
  </required_header>
  <id_info>
    <org_study_id>KingSaudU2018</org_study_id>
    <nct_id>NCT03778697</nct_id>
  </id_info>
  <brief_title>Endosleeve in Adolescents</brief_title>
  <official_title>Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New You Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Saud University</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>
      In this study, the investigators assess the safety and efficacy of endoscopic sleeve&#xD;
      gastroplasty in adolescents with obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve&#xD;
      as a middle ground between safe, albeit poorly effective medical weight loss strategies and&#xD;
      drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure&#xD;
      that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures&#xD;
      that plicate the greater curvature of the stomach. Emerging data from adult populations shows&#xD;
      an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the&#xD;
      safety and efficacy of ESG in adult patients who undergo the procedure under a standardized&#xD;
      protocol and clinical care pathway, the investigators planned to study its effects on&#xD;
      adolescents in a specialized center that offers surgical, endoscopic, and medical management&#xD;
      of obesity under a standardized protocol and care pathway.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">May 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Weight Loss</measure>
    <time_frame>One year</time_frame>
    <description>% total weight loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>One year</time_frame>
    <description>Adverse events, including hospitalization, or unplanned intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Adolescent Endosleeve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will undergo endoscopic sleeve gastroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Sleeve Gastroplasty</intervention_name>
    <description>Endoscopic full-thickness suture system to plicate the greater curvature of the stomach</description>
    <arm_group_label>Adolescent Endosleeve</arm_group_label>
    <other_name>Endosleeve</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI that is &gt;120% of the 95th percentile for age and gender&#xD;
&#xD;
          -  Written informed assent/consent, with concomitant parental consent for patients aged&#xD;
             ≤17 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;10 years&#xD;
&#xD;
          -  Age &gt;21 years&#xD;
&#xD;
          -  Presence of large hiatal hernia&#xD;
&#xD;
          -  Previous gastric surgery&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aayed R Alqahtani, MD FRCSC FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Saud University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New You Medical Center</name>
      <address>
        <city>Riyadh</city>
        <state>Central Region</state>
        <zip>11671</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 4, 2019</last_update_submitted>
  <last_update_submitted_qc>May 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Aayed Alqahtani</investigator_full_name>
    <investigator_title>Professor of Surgery, Director of Obesity Chair</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</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/NCT03778697
org study id: KingSaudU2018
nct id: NCT03778697
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators assess the safety and efficacy of endoscopic sleeve
      gastroplasty in adolescents with obesity.
Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve
      as a middle ground between safe, albeit poorly effective medical weight loss strategies and
      drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure
      that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures
      that plicate the greater curvature of the stomach. Emerging data from adult populations shows
      an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the
      safety and efficacy of ESG in adult patients who undergo the procedure under a standardized
      protocol and clinical care pathway, the investigators planned to study its effects on
      adolescents in a specialized center that offers surgical, endoscopic, and medical management
      of obesity under a standardized protocol and care pathway.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Loss
time frame: One year
description: % total weight loss
measure: Adverse events
time frame: One year
description: Adverse events, including hospitalization, or unplanned intervention
arm group label: Adolescent Endosleeve
arm group type: Experimental
description: Patients who will undergo endoscopic sleeve gastroplasty
intervention type: Procedure
intervention name: Endoscopic Sleeve Gastroplasty
description: Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
arm group label: Adolescent Endosleeve
other name: Endosleeve
criteria: 
gender: All
minimum age: 10 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aayed R Alqahtani, MD FRCSC FACS
role: Principal Investigator
affiliation: King Saud University
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Aayed Alqahtani
investigator title: Professor of Surgery, Director of Obesity Chair
mesh term: Pediatric Obesity
sharing ipd: No