xml: <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/NCT06015945</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00225786</org_study_id>
      <nct_id>NCT06015945</nct_id>
    </id_info>
    <brief_title>Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis</brief_title>
    <official_title>Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research is studying a new noninvasive device-based therapy called Transcutaneous&#xD;
        Electrical Acustimulation (TEA) to learn about its safety and how well it works as a&#xD;
        treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the&#xD;
        potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP).&#xD;
  &#xD;
        The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to&#xD;
        treat pain in chronic pancreatitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of approached participants that meet eligibility criteria</measure>
      <time_frame>Approximately 1 year (during the recruitment period)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of approached and eligible participants that provide informed consent</measure>
      <time_frame>Approximately 1 year (during the recruitment period)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.</measure>
      <time_frame>Approximately 2 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants that start the intervention among those that meet run-in period criteria.</measure>
      <time_frame>Baseline visit (V1)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention</measure>
      <time_frame>Weeks 1-4 (after the 4-week treatment period)</time_frame>
      <description>Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants that complete follow up visit at 4 weeks and return complete follow-up questionnaires at week 8, among participants that started the intervention</measure>
      <time_frame>Week 8</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Median interquartile range (IQR) of the time that it takes to complete visit number one</measure>
      <time_frame>Baseline visit (V1)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Median interquartile range (IQR) of the time that it takes to complete visit number two</measure>
      <time_frame>4 weeks (after treatment period)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants that come for visit 1 and complete all the surveys involved in the study</measure>
      <time_frame>Approximately 2 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of study surveys that are completed per protocol</measure>
      <time_frame>Baseline visit (V1) to 8 weeks (V3)</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Chronic Pancreatitis</condition>
    <arm_group>
      <arm_group_label>Transcutaneous Electrical Acustimulation (TEA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous Electrical Acustimulation (TEA)</intervention_name>
      <description>The severity and frequency participants pain will be measured during a run-in period of 2 weeks with to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.&#xD;
  In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.</description>
      <arm_group_label>Transcutaneous Electrical Acustimulation (TEA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a&#xD;
               previously validated Mayo scoring system that uses morphologic and functional&#xD;
               criteria, or endosonographic features suggestive or consistent with CP based on&#xD;
               Rosemont criteria.&#xD;
  &#xD;
            -  Abdominal pain present at least once within the last month&#xD;
  &#xD;
            -  Willing and able to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breastfeeding mother&#xD;
  &#xD;
            -  Imprisoned individuals&#xD;
  &#xD;
            -  Non-English speaking patients&#xD;
  &#xD;
            -  Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with&#xD;
               Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other)&#xD;
  &#xD;
            -  Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde&#xD;
               cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS)&#xD;
  &#xD;
            -  Recent history of acute pancreatitis as defined by the Revised Atlanta Classification&#xD;
               within a month prior to enrollment&#xD;
  &#xD;
            -  Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off&#xD;
               necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6&#xD;
               months&#xD;
  &#xD;
            -  Self-reported daily use of opioids for &gt; 12 months for weak opioids (codeine, tramadol&#xD;
               and hydrocodone) or &gt; 6 months for strong opioids (other opioids) in the last two&#xD;
               years.&#xD;
  &#xD;
          -Self-reported ongoing illicit drug use or abuse-&#xD;
  &#xD;
            -  Suspected or diagnosed pancreatic cancer&#xD;
  &#xD;
            -  Receiving chemotherapy for cancer&#xD;
  &#xD;
            -  Known allergy to adhesive electrocardiogram (ECG) electrodes&#xD;
  &#xD;
            -  Patients with bilateral below the knee amputation&#xD;
  &#xD;
            -  Patients with lower extremity paralysis&#xD;
  &#xD;
            -  Patient is participating in another clinical trial&#xD;
  &#xD;
            -  Patients with an implantable electrical stimulation device.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jorge Machicado, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Colin Burnett</last_name>
      <phone>734-647-2806</phone>
      <email>bucolin@med.umich.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jorge Machicado, MD</last_name>
      <phone>734-647-9252</phone>
      <email>machicad@umich.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Colin Burnett</last_name>
        <phone>734-647-2806</phone>
        <email>bucolin@med.umich.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jorge Machicado, MD</last_name>
        <phone>734-647-9252</phone>
        <email>machicad@umich.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jorge Machicado, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Jorge Machicado, MD, MPH</investigator_full_name>
      <investigator_title>Assistant Professor of Internal Medicine</investigator_title>
    </responsible_party>
    <keyword>Abdominal pain</keyword>
    <keyword>Transcutaneous Acustimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatitis</mesh_term>
      <mesh_term>Pancreatitis, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015945
  org study id: HUM00225786
  nct id: NCT06015945
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This research is studying a new noninvasive device-based therapy called Transcutaneous
        Electrical Acustimulation (TEA) to learn about its safety and how well it works as a
        treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the
        potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP).
  
        The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to
        treat pain in chronic pancreatitis.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of approached participants that meet eligibility criteria
  time frame: Approximately 1 year (during the recruitment period)
  measure: Proportion of approached and eligible participants that provide informed consent
  time frame: Approximately 1 year (during the recruitment period)
  measure: Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.
  time frame: Approximately 2 weeks
  measure: Proportion of participants that start the intervention among those that meet run-in period criteria.
  time frame: Baseline visit (V1)
  measure: Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention
  time frame: Weeks 1-4 (after the 4-week treatment period)
  description: Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity.
  measure: Proportion of participants that complete follow up visit at 4 weeks and return complete follow-up questionnaires at week 8, among participants that started the intervention
  time frame: Week 8
  measure: Median interquartile range (IQR) of the time that it takes to complete visit number one
  time frame: Baseline visit (V1)
  measure: Median interquartile range (IQR) of the time that it takes to complete visit number two
  time frame: 4 weeks (after treatment period)
  measure: Proportion of participants that come for visit 1 and complete all the surveys involved in the study
  time frame: Approximately 2 weeks
  measure: Proportion of study surveys that are completed per protocol
  time frame: Baseline visit (V1) to 8 weeks (V3)
  arm group label: Transcutaneous Electrical Acustimulation (TEA)
  arm group type: Experimental
  intervention type: Device
  intervention name: Transcutaneous Electrical Acustimulation (TEA)
  description: The severity and frequency participants pain will be measured during a run-in period of 2 weeks with to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening.
  In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.
  arm group label: Transcutaneous Electrical Acustimulation (TEA)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jorge Machicado, MD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Colin Burnett
  phone: 734-647-2806
  email: bucolin@med.umich.edu
  last name: Jorge Machicado, MD
  phone: 734-647-9252
  email: machicad@umich.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Jorge Machicado, MD, MPH
  investigator title: Assistant Professor of Internal Medicine
  mesh term: Pancreatitis
  mesh term: Pancreatitis, Chronic
  sharing ipd: No