<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/NCT01697397</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-2012-001</org_study_id>
    <nct_id>NCT01697397</nct_id>
  </id_info>
  <brief_title>Gastrointestinal Myoelectric Activity Protocol, the G-Tech EEnG Protocol</brief_title>
  <official_title>A Feasibility Study For Monitoring And Recording Gastrointestinal Myoelectric Activity In Subjects With Suspected Or Diagnosed Irritable Bowel Syndrome (Lbs) And Reports Of GI Pain And Asymptomatic Subjects Without Lbs And GI Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G-Tech Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eminence Clinical Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>G-Tech Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity&#xD;
      in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain&#xD;
      and asymptomatic subjects without IBS and GI pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-arm, non-randomized feasibility study has been designed to transcutaneously&#xD;
      detect and monitor myoelectric intestinal signals temporally associated with the symptoms of&#xD;
      patients who report pain and have suspected or diagnosed IBS, and in controls [subjects&#xD;
      without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Device Success defined as the ability to record myoelectric signals in study subjects.</measure>
    <time_frame>Procedure</time_frame>
  </primary_outcome>
  <enrollment type="Actual">88</enrollment>
  <condition>Gastrointestinal Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Irritable bowel syndrome, functional bowel disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        General Eligibility Criteria:&#xD;
&#xD;
        General Inclusion Criteria&#xD;
&#xD;
          -  Willing and able to provide informed consent;&#xD;
&#xD;
          -  Eighteen (18) years of age or older;&#xD;
&#xD;
          -  Willing and able to follow a specified study procedure regimen;&#xD;
&#xD;
          -  No known allergy to commercially available food or drink required by specified study&#xD;
             procedure regimen;&#xD;
&#xD;
          -  Willing and able to recline and remain still during the recordings.&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          -  Subject has an implantable device such as a pacemaker, defibrillator, nerve&#xD;
             stimulator, insulin pump, automatic analgesic pump, or other automated implanted&#xD;
             medical device;&#xD;
&#xD;
          -  Known allergy to isopropyl (rubbing) alcohol;&#xD;
&#xD;
          -  Known allergy to Ag/AgCl electrodes;&#xD;
&#xD;
          -  Known allergy to glue adhesive (electrode adhesive);&#xD;
&#xD;
          -  Dietary restrictions not permitting intake of food or drink required by this protocol;&#xD;
&#xD;
          -  Dietary restrictions not permitting four (4) hour fasting period prior to start of&#xD;
             myoelectric recording;&#xD;
&#xD;
          -  Subject is pregnant or suspects pregnancy;&#xD;
&#xD;
          -  Open sores or wounds on the abdomen;&#xD;
&#xD;
          -  Any injury in or around the area of electrode placement that would cause pain with&#xD;
             gentle pressure required for electrode and lead wire placement;&#xD;
&#xD;
          -  Weight &gt; 300 lbs (136 Kg) (excess weight can interfere with quality of the signals).&#xD;
&#xD;
        IBS With Complaints of GI Pain Eligibility Criteria IBS With Complaints of Pain Inclusion&#xD;
        Criteria All answers must be &quot;YES&quot; to the All of the Following Inclusion Criteria Prior&#xD;
        diagnosis of IBS and complaints of GI pain IBS With Complaints of Pain Exclusion Criteria&#xD;
        All answers must be &quot;NO&quot; to the All of the Following Exclusion Criteria Functional&#xD;
        dyspepsia; No reports of GI pain, past or present.&#xD;
&#xD;
        Control Subjects Eligibility Criteria Subjects who do NOT have a prior diagnosis of&#xD;
        functional GI disorder&#xD;
&#xD;
        Control Subjects Inclusion Criteria All answers must be &quot;YES&quot; to the All of the Following&#xD;
        Inclusion Criteria&#xD;
&#xD;
        No prior diagnosis IBS; No complaints of GI pain.&#xD;
&#xD;
        Control Subjects Exclusion Criteria All answers must be &quot;NO&quot; to the All of the Following&#xD;
        Exclusion Criteria Current diagnosis of any GI disorder; Current or recent complaints of GI&#xD;
        pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prince Shah, MD</last_name>
    <role>Study Chair</role>
    <affiliation>G-Tech Chief Medical Officer and Medical Monitor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>G-Tech Corporation</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.gtechmedical.com</url>
    <description>Description of functional GI disorders, and detailed description of myoelectric science.</description>
  </link>
  <reference>
    <citation>Anand Navalgund, PhD, Steve Axelrod, PhD, George Triadafilopoulos, MD2Feasibility of measuring the contractile electrical complex over 72 hours in a healthy human subject using a wearable, wireless electrode patch. Abstract submitted to AGA IBS Conference 2015.</citation>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>August 11, 2015</last_update_submitted>
  <last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irritable bowel syndrome</keyword>
  <keyword>IBS</keyword>
  <keyword>Gastrointestinal pain</keyword>
  <keyword>Gastrointestinal functional disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 30, 2015</submitted>
    <returned>December 30, 2015</returned>
    <submitted>January 29, 2016</submitted>
    <returned>February 26, 2016</returned>
    <submitted>February 29, 2016</submitted>
    <returned>March 30, 2016</returned>
    <submitted>September 24, 2016</submitted>
    <returned>November 16, 2016</returned>
    <submitted>June 30, 2017</submitted>
    <returned>July 28, 2017</returned>
    <submitted>August 25, 2017</submitted>
    <returned>September 22, 2017</returned>
    <submitted>April 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT01697397
org study id: CLP-2012-001
nct id: NCT01697397
lead sponsor: 
collaborator: 
has dmc: No
A feasibility study for monitoring and recording gastrointestinal (GI) myoelectric activity
      in subjects with suspected or diagnosed irritable bowel syndrome (IBS) and reports of GI pain
      and asymptomatic subjects without IBS and GI pain.
This single-arm, non-randomized feasibility study has been designed to transcutaneously
      detect and monitor myoelectric intestinal signals temporally associated with the symptoms of
      patients who report pain and have suspected or diagnosed IBS, and in controls [subjects
      without suspected IBS or diagnosis of IBS and prior and/or current complaints of pain].
observational model: Case-Control
time perspective: Prospective
measure: Device Success defined as the ability to record myoelectric signals in study subjects.
time frame: Procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Prince Shah, MD
role: Study Chair
affiliation: G-Tech Chief Medical Officer and Medical Monitor
facility: 
country: United States
url: http://www.gtechmedical.com
description: Description of functional GI disorders, and detailed description of myoelectric science.
citation: Anand Navalgund, PhD, Steve Axelrod, PhD, George Triadafilopoulos, MD2Feasibility of measuring the contractile electrical complex over 72 hours in a healthy human subject using a wearable, wireless electrode patch. Abstract submitted to AGA IBS Conference 2015.
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
submitted: November 30, 2015
returned: December 30, 2015
submitted: January 29, 2016
returned: February 26, 2016
submitted: February 29, 2016
returned: March 30, 2016
submitted: September 24, 2016
returned: November 16, 2016
submitted: June 30, 2017
returned: July 28, 2017
submitted: August 25, 2017
returned: September 22, 2017
submitted: April 20, 2023