<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/NCT04411823</url>
  </required_header>
  <id_info>
    <org_study_id>19-000348</org_study_id>
    <nct_id>NCT04411823</nct_id>
  </id_info>
  <brief_title>Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction</brief_title>
  <official_title>Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers are trying to identify predictors for gastroesophageal reflux disease after&#xD;
      sleeve gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure&#xD;
      parameters from endoscopy and EndoFLIP device to develop a prediction model for&#xD;
      post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper&#xD;
      endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after&#xD;
      surgery and complete questionnaires during follow-ups up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Worsening or new-onset gastroesophageal reflux disease</measure>
    <time_frame>Baseline, 6 months, and 5 years</time_frame>
    <description>Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <condition>Sleeve Gastrectomy</condition>
  <condition>Bariatric Surgery Complication</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EndoFLIP measurement</intervention_name>
    <description>EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients &gt; 18 years&#xD;
&#xD;
          -  BMI 30 or greater kg/m2&#xD;
&#xD;
          -  Participants can give a consent to the procedure&#xD;
&#xD;
          -  Participants have no contraindications to LSG (gastric ulceration)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.&#xD;
&#xD;
          -  Patients who have evidence of a major motility abnormality defined by the Chicago&#xD;
             classification version 3.0 (achalasia, absent contractility, esophagogastric junction&#xD;
             outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)&#xD;
&#xD;
          -  Patients with hiatal hernia &gt; 3 cm&#xD;
&#xD;
          -  Patients with previous esophageal or stomach surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barham Abu Dayyeh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Lemke</last_name>
    <phone>5072663317</phone>
    <email>Lemke.Elizabeth@mayo.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abi Stromme</last_name>
      <phone>507-538-8238</phone>
      <email>DLRSTABUDAYYEHLAB@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Lemke</last_name>
      <phone>507-266-3317</phone>
      <email>Lemke.elizabeth@mayo.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Barham Abu Dayyeh, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Omar Ghanem, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Barham K. Abu Dayyeh, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gastroesophageal Reflux</keyword>
  <keyword>Sleeve gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</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/NCT04411823
org study id: 19-000348
nct id: NCT04411823
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Researchers are trying to identify predictors for gastroesophageal reflux disease after
      sleeve gastrectomy.
Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure
      parameters from endoscopy and EndoFLIP device to develop a prediction model for
      post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper
      endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after
      surgery and complete questionnaires during follow-ups up to 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Worsening or new-onset gastroesophageal reflux disease
time frame: Baseline, 6 months, and 5 years
description: Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD.
arm group label: Intervention arm
arm group type: Experimental
description: Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
intervention type: Device
intervention name: EndoFLIP measurement
description: EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barham Abu Dayyeh, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Elizabeth Lemke
phone: 5072663317
email: Lemke.Elizabeth@mayo.edu
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Barham K. Abu Dayyeh, M.D.
investigator title: Principal Investigator
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic