<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/NCT04494048</url>
  </required_header>
  <id_info>
    <org_study_id>1510016654</org_study_id>
    <nct_id>NCT04494048</nct_id>
  </id_info>
  <brief_title>Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry</brief_title>
  <acronym>EBT</acronym>
  <official_title>Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry study is to collect data through medical chart review and in&#xD;
      patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs).&#xD;
      This is a retrospective and prospective, observational, medical chart review study for at&#xD;
      least 6 standard of care visits up to 5 years after a subject consents for study&#xD;
      participation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs,&#xD;
      endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small&#xD;
      bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or&#xD;
      in conjunction with other weight loss treatment modules for patients who cannot or do not&#xD;
      want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30&#xD;
      kg/m2) or BMI &gt;27 with comorbidities.&#xD;
&#xD;
      This research is being done in order to find out if endoscopic bariatric therapies work as&#xD;
      well as, or better or worse than, other currently available treatment modules to achieve&#xD;
      weight loss.&#xD;
&#xD;
      Laboratory data, patient characteristics, imaging, histology will be collected. In certain&#xD;
      patients - after specific consent extra blood may be collected for research purposes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 5, 2016</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of weight of the various bariatric therapies</measure>
    <time_frame>Baseline, 1 month, 6 months, and 1 year post procedure</time_frame>
    <description>Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of procedure measured by in the number of adverse events of procedure</measure>
    <time_frame>at baseline</time_frame>
    <description>Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of procedure measured by in the number of adverse events that occur within 30 days</measure>
    <time_frame>Within 30 days of the procedure</time_frame>
    <description>Number of adverse events; Type (unexpected, expected, related, possibly related)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success of each bariatric therapy.</measure>
    <time_frame>through study completion at one year.</time_frame>
    <description>Technical success is the technical success of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and Improvement in comorbidities</measure>
    <time_frame>6 months, 1 year post procedure</time_frame>
    <description>measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and Improvement in comorbidities</measure>
    <time_frame>6 months, 1 year post procedure</time_frame>
    <description>measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change and Improvement in comorbidities</measure>
    <time_frame>6 months, 1 year post procedure</time_frame>
    <description>measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of Endoscopic Bariatric Therapies on reflux</measure>
    <time_frame>Baseline, 6 months,and 1 year post procedure</time_frame>
    <description>measuring change in gastrointestinal reflux disease (GERD) questionnaire answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of Endoscopic Bariatric Therapies on reflux</measure>
    <time_frame>Baseline, 6 months,and 1 year post procedure</time_frame>
    <description>measuring change in ph measurement on ph manometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease</measure>
    <time_frame>Baseline, 6 months,and 1 year post procedure</time_frame>
    <description>Measuring change in fibroscan score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease</measure>
    <time_frame>Baseline, 6 months,and 1 year post procedure</time_frame>
    <description>Measuring change in liver biopsy results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease</measure>
    <time_frame>Baseline, 6 months,and 1 year post procedure</time_frame>
    <description>Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">9999</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <condition>Gastro Esophageal Reflux</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Endoscopic Bariatric Therapies (EBT).</arm_group_label>
    <description>patients undergoing Endoscopic Bariatric Therapies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endoscopic Bariatric Therapies</intervention_name>
    <description>Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy</description>
    <arm_group_label>Endoscopic Bariatric Therapies (EBT).</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who will undergo Endoscopic bariatric therapies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who is considering undergoing EBT for weight loss within 6 months, or has&#xD;
             undergone clinically indicated EBT for weight loss within the past 6 months&#xD;
&#xD;
          -  Above or equal to 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient who has not undergone or will undergo EBT for weight loss&#xD;
&#xD;
          -  Below 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Reem Z Sharaiha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reem Z Sharaiha, MD, MSc.</last_name>
    <phone>646-962-2382</phone>
    <email>rzs9001@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea M Herr, NP</last_name>
    <phone>646-962-2382</phone>
    <email>anb9057@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reem Z Sharaiha, MD</last_name>
      <phone>646-962-2382</phone>
      <email>rzs9001@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Andrea M Herr, NP</last_name>
      <phone>6469622382</phone>
      <email>anb9057@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Reem Z Sharaiha, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</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>Gastroesophageal Reflux</mesh_term>
    <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/NCT04494048
org study id: 1510016654
nct id: NCT04494048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this registry study is to collect data through medical chart review and in
      patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs).
      This is a retrospective and prospective, observational, medical chart review study for at
      least 6 standard of care visits up to 5 years after a subject consents for study
      participation.
Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs,
      endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small
      bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or
      in conjunction with other weight loss treatment modules for patients who cannot or do not
      want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30
      kg/m2) or BMI >27 with comorbidities.

      This research is being done in order to find out if endoscopic bariatric therapies work as
      well as, or better or worse than, other currently available treatment modules to achieve
      weight loss.

      Laboratory data, patient characteristics, imaging, histology will be collected. In certain
      patients - after specific consent extra blood may be collected for research purposes.
observational model: Other
time perspective: Other
measure: Change of weight of the various bariatric therapies
time frame: Baseline, 1 month, 6 months, and 1 year post procedure
description: Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.
measure: Safety of procedure measured by in the number of adverse events of procedure
time frame: at baseline
description: Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline
measure: Safety of procedure measured by in the number of adverse events that occur within 30 days
time frame: Within 30 days of the procedure
description: Number of adverse events; Type (unexpected, expected, related, possibly related)
measure: Technical success of each bariatric therapy.
time frame: through study completion at one year.
description: Technical success is the technical success of the procedure.
measure: Change and Improvement in comorbidities
time frame: 6 months, 1 year post procedure
description: measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm
measure: Change and Improvement in comorbidities
time frame: 6 months, 1 year post procedure
description: measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg
measure: Change and Improvement in comorbidities
time frame: 6 months, 1 year post procedure
description: measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)
measure: Change in the effect of Endoscopic Bariatric Therapies on reflux
time frame: Baseline, 6 months,and 1 year post procedure
description: measuring change in gastrointestinal reflux disease (GERD) questionnaire answers
measure: Change in the effect of Endoscopic Bariatric Therapies on reflux
time frame: Baseline, 6 months,and 1 year post procedure
description: measuring change in ph measurement on ph manometry
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
time frame: Baseline, 6 months,and 1 year post procedure
description: Measuring change in fibroscan score
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
time frame: Baseline, 6 months,and 1 year post procedure
description: Measuring change in liver biopsy results
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
time frame: Baseline, 6 months,and 1 year post procedure
description: Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )
arm group label: Endoscopic Bariatric Therapies (EBT).
description: patients undergoing Endoscopic Bariatric Therapies
intervention type: Other
intervention name: Endoscopic Bariatric Therapies
description: Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy
arm group label: Endoscopic Bariatric Therapies (EBT).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
last name: Reem Z Sharaiha, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Reem Z Sharaiha, MD, MSc.
phone: 646-962-2382
email: rzs9001@med.cornell.edu
last name: Andrea M Herr, NP
phone: 646-962-2382
email: anb9057@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Weight Loss
sharing ipd: No