<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/NCT03774485</url>
  </required_header>
  <id_info>
    <org_study_id>IRB48539</org_study_id>
    <nct_id>NCT03774485</nct_id>
  </id_info>
  <brief_title>Myoelectric GutPrint-Crohn's Disease</brief_title>
  <acronym>Gutcheck-CD</acronym>
  <official_title>Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>G-Tech Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford 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>
      A feasibility study for assessing and recording myoelectric activity in patients for early&#xD;
      detection of flare in patients with Crohn's disease and differentiating the myoelectric&#xD;
      signals from Crohn's disease patients in remission state and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares&#xD;
      despite aggressive therapy. Flares are often difficult to predict. The goal of disease&#xD;
      monitoring is to identify patients at risk for flare in order to treat earlier, with the hope&#xD;
      of maintaining remission and avoiding irreversible bowel damage such as fistulas and&#xD;
      strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows&#xD;
      in some cases ability to predict flare and determine deep remission, this procedure is&#xD;
      invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal&#xD;
      pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with&#xD;
      alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility&#xD;
      patterns in CD flare and remission states may be helpful for prediction of flare for guiding&#xD;
      appropriate therapy.&#xD;
&#xD;
      The goal of this study is to determine whether the motility patterns measured by the G-Tech&#xD;
      non-invasive, wireless patch system can provide useful insight for routine CD care. Three&#xD;
      G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch&#xD;
      to carry with them for the next 3-6 days. Data from the patches is processed offline to&#xD;
      obtain motility patterns of the stomach, small intestine and colon. These patterns represent&#xD;
      a rich trove of data that can be studied in multiple ways to provide comparisons and insight.&#xD;
      Some examples are the overall strength of motor activity in each of the organs, the duration&#xD;
      and rhythmicity, the correlation with meals, pain events and bowel movements, day to day&#xD;
      variations and their correlation with symptoms, and diurnal effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Myoelectric activity pattern (physiological parameters)</measure>
    <time_frame>change from baseline at 1 month, 3 months and 6 months after recruitment</time_frame>
    <description>Myoelectric activity pattern in Crohn's disease patients versus healthy controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of anticipated Adverse Events</measure>
    <time_frame>Up to 6 days</time_frame>
    <description>Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unanticipated adverse device effects</measure>
    <time_frame>Up to 6 days</time_frame>
    <description>Unanticipated adverse device effects</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's disease (remission state)</arm_group_label>
    <description>Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (remission state). The investigator does not change the routine medical care of study participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's disease (flare state)</arm_group_label>
    <description>Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (flare state). The investigator does not change the routine medical care of study participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>G-Tech Gutcheck Myoelectric recording device</intervention_name>
    <description>Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.</description>
    <arm_group_label>Crohn's disease (flare state)</arm_group_label>
    <arm_group_label>Crohn's disease (remission state)</arm_group_label>
    <arm_group_label>Healthy controls</arm_group_label>
    <other_name>Gastro-intestinal electrical recording</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects without gastrointestinal symptoms or history of gastrointestinal&#xD;
        surgeries.&#xD;
&#xD;
        Patients with Crohn's disease in remission state or flare state (exclude severe Crohn's&#xD;
        disease due to complexity of disease, complication, and potential needs for surgery; on new&#xD;
        medications 【e.g. within 3 months of enrollment】 known to alter GI motility or bowel&#xD;
        surgeries due to potential impact on the G-Tech results)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Crohn's disease and healthy subjects above the age of 18 who are able to&#xD;
             give consent and follow direction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients or subjects under the age of 18, pregnant, and those unable to give consent&#xD;
             or follow direction.&#xD;
&#xD;
          -  Healthy subjects with gastrointestinal symptoms or history of gastrointestinal&#xD;
             surgeries.&#xD;
&#xD;
          -  Patients with severe Crohn's disease due to complexity of disease, complication, and&#xD;
             potential needs for surgery.&#xD;
&#xD;
          -  Patients with bowel surgeries due to potential impact on the G-Tech results. For&#xD;
             similar reasons we will exclude patients on new medications (e.g. within 3 months of&#xD;
             enrollment) known to alter GI motility but we will not exclude patients on stable&#xD;
             doses or chronic GI motility agents as this mimics &quot;real world&quot; in which the G-Tech&#xD;
             patch will be used and we can learn the stability of the motility recordings over time&#xD;
             in stable patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sidhartha Sinha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sidhartha Sinha, MD</last_name>
    <phone>650-497-6216</phone>
    <email>sidsinha@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steve Axelrod, PhD</last_name>
    <phone>650-269-1479</phone>
    <email>steve.axelrod@gtechhealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sidhartha Sinha, MD</last_name>
      <email>sidsinha@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Akshar Patel, BA</last_name>
      <phone>4088575682</phone>
      <email>aksharp1@stanford.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dua MM, Navalgund A, Axelrod S, Axelrod L, Worth PJ, Norton JA, Poultsides GA, Triadafilopoulos G, Visser BC. Monitoring gastric myoelectric activity after pancreaticoduodenectomy for diet &quot;readiness&quot;. Am J Physiol Gastrointest Liver Physiol. 2018 Nov 1;315(5):G743-G751. doi: 10.1152/ajpgi.00074.2018. Epub 2018 Jul 26.</citation>
    <PMID>30048596</PMID>
  </reference>
  <reference>
    <citation>Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.</citation>
    <PMID>30390183</PMID>
  </reference>
  <reference>
    <citation>Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.</citation>
    <PMID>17653185</PMID>
  </reference>
  <reference>
    <citation>Schoepfer AM, Trummler M, Seeholzer P, Seibold-Schmid B, Seibold F. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis. 2008 Jan;14(1):32-9. doi: 10.1002/ibd.20275.</citation>
    <PMID>17924558</PMID>
  </reference>
  <reference>
    <citation>Abdalla MI, Sandler RS, Kappelman MD, Martin CF, Chen W, Anton K, Long MD. Prevalence and Impact of Inflammatory Bowel Disease-Irritable Bowel Syndrome on Patient-reported Outcomes in CCFA Partners. Inflamm Bowel Dis. 2017 Feb;23(2):325-331. doi: 10.1097/MIB.0000000000001017.</citation>
    <PMID>28092305</PMID>
  </reference>
  <reference>
    <citation>Barratt SM, Leeds JS, Robinson K, Lobo AJ, McAlindon ME, Sanders DS. Prodromal irritable bowel syndrome may be responsible for delays in diagnosis in patients presenting with unrecognized Crohn's disease and celiac disease, but not ulcerative colitis. Dig Dis Sci. 2011 Nov;56(11):3270-5. doi: 10.1007/s10620-011-1783-y. Epub 2011 Jun 22.</citation>
    <PMID>21695401</PMID>
  </reference>
  <reference>
    <citation>Grover M, Herfarth H, Drossman DA. The functional-organic dichotomy: postinfectious irritable bowel syndrome and inflammatory bowel disease-irritable bowel syndrome. Clin Gastroenterol Hepatol. 2009 Jan;7(1):48-53. doi: 10.1016/j.cgh.2008.08.032. Epub 2008 Sep 3.</citation>
    <PMID>18848909</PMID>
  </reference>
  <reference>
    <citation>von Stein P, Lofberg R, Kuznetsov NV, Gielen AW, Persson JO, Sundberg R, Hellstrom K, Eriksson A, Befrits R, Ost A, von Stein OD. Multigene analysis can discriminate between ulcerative colitis, Crohn's disease, and irritable bowel syndrome. Gastroenterology. 2008 Jun;134(7):1869-81; quiz 2153-4. doi: 10.1053/j.gastro.2008.02.083. Epub 2008 Mar 2.</citation>
    <PMID>18466904</PMID>
  </reference>
  <reference>
    <citation>Minderhoud IM, Oldenburg B, Wismeijer JA, van Berge Henegouwen GP, Smout AJ. IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior. Dig Dis Sci. 2004 Mar;49(3):469-74. doi: 10.1023/b:ddas.0000020506.84248.f9.</citation>
    <PMID>15139501</PMID>
  </reference>
  <reference>
    <citation>Bickelhaupt S, Pazahr S, Chuck N, Blume I, Froehlich JM, Cattin R, Raible S, Bouquet H, Bill U, Rogler G, Frei P, Boss A, Patak MA. Crohn's disease: small bowel motility impairment correlates with inflammatory-related markers C-reactive protein and calprotectin. Neurogastroenterol Motil. 2013 Jun;25(6):467-73. doi: 10.1111/nmo.12088. Epub 2013 Mar 18.</citation>
    <PMID>23495824</PMID>
  </reference>
  <reference>
    <citation>Bickelhaupt S, Froehlich JM, Cattin R, Patuto N, Tutuian R, Wentz KU, Culmann JL, Raible S, Bouquet H, Bill U, Patak MA. Differentiation between active and chronic Crohn's disease using MRI small-bowel motility examinations - initial experience. Clin Radiol. 2013 Dec;68(12):1247-53. doi: 10.1016/j.crad.2013.06.024. Epub 2013 Aug 21.</citation>
    <PMID>23973163</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sidhartha Ranjit Sinha</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will share the data through publication of results. Individual participant data was not promised to be shared.</ipd_description>
  </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/NCT03774485
org study id: IRB48539
nct id: NCT03774485
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A feasibility study for assessing and recording myoelectric activity in patients for early
      detection of flare in patients with Crohn's disease and differentiating the myoelectric
      signals from Crohn's disease patients in remission state and healthy controls.
Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares
      despite aggressive therapy. Flares are often difficult to predict. The goal of disease
      monitoring is to identify patients at risk for flare in order to treat earlier, with the hope
      of maintaining remission and avoiding irreversible bowel damage such as fistulas and
      strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows
      in some cases ability to predict flare and determine deep remission, this procedure is
      invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal
      pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with
      alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility
      patterns in CD flare and remission states may be helpful for prediction of flare for guiding
      appropriate therapy.

      The goal of this study is to determine whether the motility patterns measured by the G-Tech
      non-invasive, wireless patch system can provide useful insight for routine CD care. Three
      G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch
      to carry with them for the next 3-6 days. Data from the patches is processed offline to
      obtain motility patterns of the stomach, small intestine and colon. These patterns represent
      a rich trove of data that can be studied in multiple ways to provide comparisons and insight.
      Some examples are the overall strength of motor activity in each of the organs, the duration
      and rhythmicity, the correlation with meals, pain events and bowel movements, day to day
      variations and their correlation with symptoms, and diurnal effects.
observational model: Case-Control
time perspective: Prospective
measure: Myoelectric activity pattern (physiological parameters)
time frame: change from baseline at 1 month, 3 months and 6 months after recruitment
description: Myoelectric activity pattern in Crohn's disease patients versus healthy controls
measure: Number of anticipated Adverse Events
time frame: Up to 6 days
description: Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
measure: Number of unanticipated adverse device effects
time frame: Up to 6 days
description: Unanticipated adverse device effects
arm group label: Healthy controls
description: Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants.
arm group label: Crohn's disease (remission state)
description: Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (remission state). The investigator does not change the routine medical care of study participants.
arm group label: Crohn's disease (flare state)
description: Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (flare state). The investigator does not change the routine medical care of study participants.
intervention type: Device
intervention name: G-Tech Gutcheck Myoelectric recording device
description: Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
arm group label: Crohn's disease (flare state)
arm group label: Crohn's disease (remission state)
arm group label: Healthy controls
other name: Gastro-intestinal electrical recording
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sidhartha Sinha, MD
role: Principal Investigator
affiliation: Stanford University
last name: Sidhartha Sinha, MD
phone: 650-497-6216
email: sidsinha@stanford.edu
last name: Steve Axelrod, PhD
phone: 650-269-1479
email: steve.axelrod@gtechhealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Dua MM, Navalgund A, Axelrod S, Axelrod L, Worth PJ, Norton JA, Poultsides GA, Triadafilopoulos G, Visser BC. Monitoring gastric myoelectric activity after pancreaticoduodenectomy for diet "readiness". Am J Physiol Gastrointest Liver Physiol. 2018 Nov 1;315(5):G743-G751. doi: 10.1152/ajpgi.00074.2018. Epub 2018 Jul 26.
PMID: 30048596
citation: Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.
PMID: 30390183
citation: Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
PMID: 17653185
citation: Schoepfer AM, Trummler M, Seeholzer P, Seibold-Schmid B, Seibold F. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis. 2008 Jan;14(1):32-9. doi: 10.1002/ibd.20275.
PMID: 17924558
citation: Abdalla MI, Sandler RS, Kappelman MD, Martin CF, Chen W, Anton K, Long MD. Prevalence and Impact of Inflammatory Bowel Disease-Irritable Bowel Syndrome on Patient-reported Outcomes in CCFA Partners. Inflamm Bowel Dis. 2017 Feb;23(2):325-331. doi: 10.1097/MIB.0000000000001017.
PMID: 28092305
citation: Barratt SM, Leeds JS, Robinson K, Lobo AJ, McAlindon ME, Sanders DS. Prodromal irritable bowel syndrome may be responsible for delays in diagnosis in patients presenting with unrecognized Crohn's disease and celiac disease, but not ulcerative colitis. Dig Dis Sci. 2011 Nov;56(11):3270-5. doi: 10.1007/s10620-011-1783-y. Epub 2011 Jun 22.
PMID: 21695401
citation: Grover M, Herfarth H, Drossman DA. The functional-organic dichotomy: postinfectious irritable bowel syndrome and inflammatory bowel disease-irritable bowel syndrome. Clin Gastroenterol Hepatol. 2009 Jan;7(1):48-53. doi: 10.1016/j.cgh.2008.08.032. Epub 2008 Sep 3.
PMID: 18848909
citation: von Stein P, Lofberg R, Kuznetsov NV, Gielen AW, Persson JO, Sundberg R, Hellstrom K, Eriksson A, Befrits R, Ost A, von Stein OD. Multigene analysis can discriminate between ulcerative colitis, Crohn's disease, and irritable bowel syndrome. Gastroenterology. 2008 Jun;134(7):1869-81; quiz 2153-4. doi: 10.1053/j.gastro.2008.02.083. Epub 2008 Mar 2.
PMID: 18466904
citation: Minderhoud IM, Oldenburg B, Wismeijer JA, van Berge Henegouwen GP, Smout AJ. IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior. Dig Dis Sci. 2004 Mar;49(3):469-74. doi: 10.1023/b:ddas.0000020506.84248.f9.
PMID: 15139501
citation: Bickelhaupt S, Pazahr S, Chuck N, Blume I, Froehlich JM, Cattin R, Raible S, Bouquet H, Bill U, Rogler G, Frei P, Boss A, Patak MA. Crohn's disease: small bowel motility impairment correlates with inflammatory-related markers C-reactive protein and calprotectin. Neurogastroenterol Motil. 2013 Jun;25(6):467-73. doi: 10.1111/nmo.12088. Epub 2013 Mar 18.
PMID: 23495824
citation: Bickelhaupt S, Froehlich JM, Cattin R, Patuto N, Tutuian R, Wentz KU, Culmann JL, Raible S, Bouquet H, Bill U, Patak MA. Differentiation between active and chronic Crohn's disease using MRI small-bowel motility examinations - initial experience. Clin Radiol. 2013 Dec;68(12):1247-53. doi: 10.1016/j.crad.2013.06.024. Epub 2013 Aug 21.
PMID: 23973163
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sidhartha Ranjit Sinha
investigator title: Associate Professor
mesh term: Crohn Disease
sharing ipd: No
ipd description: We will share the data through publication of results. Individual participant data was not promised to be shared.