<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/NCT04431232</url>
  </required_header>
  <id_info>
    <org_study_id>MohamedAbeid1</org_study_id>
    <nct_id>NCT04431232</nct_id>
  </id_info>
  <brief_title>Endo-Band: Endoscopic Band Ligation for Weight Loss</brief_title>
  <official_title>Endoscopic Band Ligation for Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>El Katib Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>El Katib Hospital</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>
      To the best of our knowledge, this is the first study to use endoscopic band ligation for&#xD;
      weight loss. All ligatures will be performed in the gastric body starting at the distal body;&#xD;
      5 parallel rows, with the last one in the proximal body.The entire procedure can be completed&#xD;
      in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using&#xD;
      propofol for sedation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms&#xD;
      a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in&#xD;
      the esophagus following band ligation of esophageal varices or in the antrum following band&#xD;
      ligation of GAVE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">March 7, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 7, 2024</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>Weight Loss</measure>
    <time_frame>3 months</time_frame>
    <description>BMI Change</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Band Ligation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Band ligation of gastric body for weight loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic Band Ligation</intervention_name>
    <description>Band ligation of the gastric body for weight loss</description>
    <arm_group_label>Band Ligation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 27&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for endoscopy&#xD;
&#xD;
          -  Any gastric bleeding lesions&#xD;
&#xD;
          -  Uncontrolled use of anticoagulants or NSAID's&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Abeid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Endoscopy Unit Faculty of Medicine Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Abeid, MD</last_name>
    <phone>+201001222254</phone>
    <email>mohamedabeid@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>El Katib Hospital (Celopatra Group)</name>
      <address>
        <city>Giza</city>
        <state>Dokki</state>
        <zip>12311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Abeid, MD</last_name>
      <phone>01001222254</phone>
      <email>mohamedabeid@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.</citation>
    <PMID>23808945</PMID>
  </reference>
  <reference>
    <citation>Jirapinyo P, Thompson CC. Endoscopic gastric body plication for the treatment of obesity: technical success and safety of a novel technique (with video). Gastrointest Endosc. 2020 Jun;91(6):1388-1394. doi: 10.1016/j.gie.2020.01.030. Epub 2020 Jan 28.</citation>
    <PMID>32001332</PMID>
  </reference>
  <reference>
    <citation>Abeid M, Miller KA, Kaddah T, Zaitoun N. Outcome of Primary Obesity Surgery Endolumenal Procedure as Obesity Treatment in Private Practice Setting: an Intervention Study. Obes Surg. 2019 Apr;29(4):1364-1366. doi: 10.1007/s11695-018-03698-z. No abstract available.</citation>
    <PMID>30627991</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>El Katib Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Abeid</investigator_full_name>
    <investigator_title>Consultant Gastroenterologist/ Bariatric Endoscopist Cairo University</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>BMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04431232
org study id: MohamedAbeid1
nct id: NCT04431232
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To the best of our knowledge, this is the first study to use endoscopic band ligation for
      weight loss. All ligatures will be performed in the gastric body starting at the distal body;
      5 parallel rows, with the last one in the proximal body.The entire procedure can be completed
      in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using
      propofol for sedation.
The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms
      a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in
      the esophagus following band ligation of esophageal varices or in the antrum following band
      ligation of GAVE.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Loss
time frame: 3 months
description: BMI Change
arm group label: Band Ligation
arm group type: Experimental
description: Band ligation of gastric body for weight loss
intervention type: Device
intervention name: Endoscopic Band Ligation
description: Band ligation of the gastric body for weight loss
arm group label: Band Ligation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mohamed Abeid, MD
role: Principal Investigator
affiliation: Endoscopy Unit Faculty of Medicine Cairo University
last name: Mohamed Abeid, MD
phone: +201001222254
email: mohamedabeid@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.
PMID: 23808945
citation: Jirapinyo P, Thompson CC. Endoscopic gastric body plication for the treatment of obesity: technical success and safety of a novel technique (with video). Gastrointest Endosc. 2020 Jun;91(6):1388-1394. doi: 10.1016/j.gie.2020.01.030. Epub 2020 Jan 28.
PMID: 32001332
citation: Abeid M, Miller KA, Kaddah T, Zaitoun N. Outcome of Primary Obesity Surgery Endolumenal Procedure as Obesity Treatment in Private Practice Setting: an Intervention Study. Obes Surg. 2019 Apr;29(4):1364-1366. doi: 10.1007/s11695-018-03698-z. No abstract available.
PMID: 30627991
responsible party type: Principal Investigator
investigator affiliation: El Katib Hospital
investigator full name: Mohamed Abeid
investigator title: Consultant Gastroenterologist/ Bariatric Endoscopist Cairo University
mesh term: Weight Loss