<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/NCT02233270</url>
  </required_header>
  <id_info>
    <org_study_id>32500</org_study_id>
    <nct_id>NCT02233270</nct_id>
  </id_info>
  <brief_title>Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities</brief_title>
  <acronym>AEGIS</acronym>
  <official_title>Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When compared to existing analyses: manometry, Smart Pill and lactulose breath testing,&#xD;
      external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible&#xD;
      patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel&#xD;
      contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research&#xD;
      study is designed to test the capabilities of AbStats/AEGIS to identify and associate&#xD;
      symptoms and traditional diagnostics with sound readings and correlate this data with&#xD;
      treatment outcomes and successes in standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In partnership with Dr. William Kaiser and the UCLA Wireless Health Institute, our research&#xD;
      groups are developing and validating the diagnostic capabilities of device that conducts&#xD;
      AEGIS. A belt (AbStats) fits externally around the abdomen and is embedded with acoustic&#xD;
      sensors, similar to &quot;electronic stethoscopes.&quot; The investigational software is designed to&#xD;
      continuously, safely, and comfortably monitor acoustic signals emanating from the esophagus,&#xD;
      stomach, and intestines, and stores the data in a HIPAA compliant hard drive. Through the&#xD;
      study of associating these readings with current diagnostics and treatments we anticipate&#xD;
      that the AEGIS device will eventually provide clinically interpretable information that is&#xD;
      immediately actionable. In this study, the Abstats sensor will track signals in tandem with&#xD;
      current techniques and standard of care treatments based on those diagnostics. AEGIS analysis&#xD;
      could potentially refine, support, or even replace, existing costly and invasive techniques&#xD;
      in the diagnosis of gastroparesis, intestinal psueodo-obstruction, colonic inertia, and&#xD;
      disorders related to small intestinal bacterial overgrowth (SIBO).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.</measure>
    <time_frame>At the time that the standard of care diagnostic test is performed, an expected average of 6 hours</time_frame>
    <description>Acoustic readings would be recorded concurrent with standard of care diagnostics.&#xD;
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care SmartPill transit recording.</measure>
    <time_frame>At the time the standard of care diagnostic test is performed, up to 5 days</time_frame>
    <description>Acoustic readings would be recorded concurrent with standard of care diagnostics.&#xD;
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acoustic readings of the abdominal cavity and swallowing collected via the device during standard of care breath testing.</measure>
    <time_frame>At the time the standard of care diagnostic test is performed, up to 3 hours.</time_frame>
    <description>Acoustic readings would be recorded concurrent with standard of care diagnostics.&#xD;
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Motility Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to the Cedars-Sinai Motility Program who are already scheduled to undergo&#xD;
        small bowel manometry, SmartPill, or Lactulose Hydrogen Breath Test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in&#xD;
             the Cedars-Sinai Motility Program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index that is incompatible with placement of the belt (typically BMI greater&#xD;
             than 45)&#xD;
&#xD;
          -  Abdominal wall condition that disallows topical coverage as deemed by treating&#xD;
             physician (eg abdominal wound, advanced cellulitis, draining ostomy etc)&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Have cognitive inability to follow directions&#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>Mark Pimentel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Mark Pimentel, MD</investigator_full_name>
    <investigator_title>Director, GI Motility Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT02233270
org study id: 32500
nct id: NCT02233270
lead sponsor: 
collaborator: 
has dmc: No
When compared to existing analyses: manometry, Smart Pill and lactulose breath testing,
      external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible
      patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel
      contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research
      study is designed to test the capabilities of AbStats/AEGIS to identify and associate
      symptoms and traditional diagnostics with sound readings and correlate this data with
      treatment outcomes and successes in standard of care.
In partnership with Dr. William Kaiser and the UCLA Wireless Health Institute, our research
      groups are developing and validating the diagnostic capabilities of device that conducts
      AEGIS. A belt (AbStats) fits externally around the abdomen and is embedded with acoustic
      sensors, similar to "electronic stethoscopes." The investigational software is designed to
      continuously, safely, and comfortably monitor acoustic signals emanating from the esophagus,
      stomach, and intestines, and stores the data in a HIPAA compliant hard drive. Through the
      study of associating these readings with current diagnostics and treatments we anticipate
      that the AEGIS device will eventually provide clinically interpretable information that is
      immediately actionable. In this study, the Abstats sensor will track signals in tandem with
      current techniques and standard of care treatments based on those diagnostics. AEGIS analysis
      could potentially refine, support, or even replace, existing costly and invasive techniques
      in the diagnosis of gastroparesis, intestinal psueodo-obstruction, colonic inertia, and
      disorders related to small intestinal bacterial overgrowth (SIBO).
observational model: Cohort
time perspective: Prospective
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.
time frame: At the time that the standard of care diagnostic test is performed, an expected average of 6 hours
description: Acoustic readings would be recorded concurrent with standard of care diagnostics.
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care SmartPill transit recording.
time frame: At the time the standard of care diagnostic test is performed, up to 5 days
description: Acoustic readings would be recorded concurrent with standard of care diagnostics.
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during standard of care breath testing.
time frame: At the time the standard of care diagnostic test is performed, up to 3 hours.
description: Acoustic readings would be recorded concurrent with standard of care diagnostics.
There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Pimentel, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Mark Pimentel, MD
investigator title: Director, GI Motility Program
mesh term: Congenital Abnormalities