<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/NCT04502732</url>
  </required_header>
  <id_info>
    <org_study_id>20-002882</org_study_id>
    <nct_id>NCT04502732</nct_id>
  </id_info>
  <brief_title>Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure</brief_title>
  <official_title>Direct Comparison of Short- And Long-Term Gastric Emptying By Nuclear Scintigraphy and Gastric Emptying Breath Test in Subjects Undergoing Endoscopic Gastric Remodeling For Weight Loss</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>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 study is to compare a less invasive breath test against the current&#xD;
      standard for assessing gastric (stomach) emptying. The current standard of care is a&#xD;
      procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this&#xD;
      method to a Gastric Emptying Breath Test (GEBT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of T1/2</measure>
    <time_frame>Baseline, 2 months, 6 months</time_frame>
    <description>The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an EGRWL procedure.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">7</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>NSSM and GEBT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NSSM and GEBT</intervention_name>
    <description>The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.</description>
    <arm_group_label>Observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those eligible from relevant sub-studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be 22-65 years of age at time of enrollment&#xD;
&#xD;
          -  Subjects must already be consented to 17-007934 or 19-001254&#xD;
&#xD;
          -  Subject must be agreeable and compliant with study requirements, including up to three&#xD;
             (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.&#xD;
&#xD;
          -  If female, must be post-menopausal, surgically sterile, or agree to practice a form of&#xD;
             birth control or abstinence during year of study and have negative serum HCG at&#xD;
             screening/baseline&#xD;
&#xD;
          -  Must be willing and able to travel, as needed, to the Investigator's office to&#xD;
             complete all routine follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons presently or soon to be incarcerated&#xD;
&#xD;
          -  Females who are pregnant or suspect they may be pregnant&#xD;
&#xD;
          -  Persons with nicotine and/or alcohol dependence&#xD;
&#xD;
          -  Patients with cognitive impairment that limits their ability to make autonomous&#xD;
             decisions&#xD;
&#xD;
          -  Known allergies or sensitivities to study materials (eggs and spirulina)&#xD;
&#xD;
          -  Assessed, by the physician or delegate, that enrollment would not be appropriate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</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>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>November 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</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/NCT04502732
org study id: 20-002882
nct id: NCT04502732
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare a less invasive breath test against the current
      standard for assessing gastric (stomach) emptying. The current standard of care is a
      procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this
      method to a Gastric Emptying Breath Test (GEBT).
observational model: Other
time perspective: Prospective
measure: Change of T1/2
time frame: Baseline, 2 months, 6 months
description: The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an EGRWL procedure.
arm group label: Observational
description: NSSM and GEBT
intervention type: Other
intervention name: NSSM and GEBT
description: The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.
arm group label: Observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: Barham Abu Dayyeh, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
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: Body Weight
mesh term: Weight Loss
sharing ipd: No