<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/NCT02995395</url>
  </required_header>
  <id_info>
    <org_study_id>16-005863</org_study_id>
    <nct_id>NCT02995395</nct_id>
  </id_info>
  <brief_title>Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)</brief_title>
  <official_title>The Role of the Mucosal Impedance Balloon in the Diagnosis and Treatment Eosinophilic Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sandhill Scientific</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      This study will evaluate the role the balloon mucosal impedance may have in diagnosing and&#xD;
      monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the&#xD;
      balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies.&#xD;
      Recently we completed the study &quot;Mucosal impedance in eosinophilic esophagitis and the effect&#xD;
      of treatment&quot; using a new technology allowing for direct assessment of mucosal impedance at&#xD;
      the time of routine upper endoscopy to assess esophageal integrity and disease activity and&#xD;
      alevate the need for biopsies.&#xD;
&#xD;
      For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly&#xD;
      to provide precise measurements over a broad area of esophageal epithelium, while eliminating&#xD;
      the fluids and spanning across a 10 mm luminal area using the same direct assessment as the&#xD;
      mucosal impedance at the time of routine upper endoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diminished mucosal impedance in patients with Eosinophilic Esophagitis</measure>
    <time_frame>1 year</time_frame>
    <description>Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Mucosal Impedance Balloon catheter</arm_group_label>
    <description>At the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mucosal Impedance Balloon catheter</intervention_name>
    <description>During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.&#xD;
o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.</description>
    <arm_group_label>Mucosal Impedance Balloon catheter</arm_group_label>
    <other_name>Impedance balloon testing</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper&#xD;
        endoscopy for dysphagia or GERD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults ages 18-90 undergoing clinically indicated upper endoscopy&#xD;
&#xD;
          -  Patients with EoE, defined as dysphagia with histologic finding of greater than or&#xD;
             equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6&#xD;
             weeks of twice daily proton pump inhibitor therapy&#xD;
&#xD;
          -  Patients undergoing clinically indicated upper endoscopy for indications other than&#xD;
             dysphagia or GERD with normal appearing esophageal mucosa.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Medical conditions such as severe heart or lung disease that preclude safe performance&#xD;
             of endoscopy&#xD;
&#xD;
          -  Patients with conditions known to be associated with esophageal eosinophilia,&#xD;
             including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome&#xD;
&#xD;
          -  Inability to read due to: Blindness, cognitive dysfunction, or English language&#xD;
             illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Katzka</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>February 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>David A. Katzka</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>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</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/NCT02995395
org study id: 16-005863
nct id: NCT02995395
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the role the balloon mucosal impedance may have in diagnosing and
      monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the
      balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.
The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies.
      Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect
      of treatment" using a new technology allowing for direct assessment of mucosal impedance at
      the time of routine upper endoscopy to assess esophageal integrity and disease activity and
      alevate the need for biopsies.

      For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly
      to provide precise measurements over a broad area of esophageal epithelium, while eliminating
      the fluids and spanning across a 10 mm luminal area using the same direct assessment as the
      mucosal impedance at the time of routine upper endoscopy.
observational model: Case-Only
time perspective: Prospective
measure: Diminished mucosal impedance in patients with Eosinophilic Esophagitis
time frame: 1 year
description: Patient with eosinophilic esophagitis have diminished mucosal impedance, reflecting increased permeability to allergens occurring in the esophagus. The impedance measurements are also variable throughout the esophageal mucosa reflecting the patchy histology of eosinophilic esophagitis.
arm group label: Mucosal Impedance Balloon catheter
description: At the conclusion of the endoscopy, all fluids will be aspirated from the esophagus. The endoscope will then be left in place in the mid-esophagus and a custom Mucosal Impedance (MI) balloon assembly four axial arrays of 10 sensors (total of 40 sensors) will be positioned along the esophageal mucosal wall under direct visualization to directly measure MI at uniform intervals. Once in place, impedance readings will be recorded for a total of 2 minutes. At this point both the endoscope and impedance catheter will be withdrawn simultaneously.
intervention type: Device
intervention name: Mucosal Impedance Balloon catheter
description: During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.
o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.
arm group label: Mucosal Impedance Balloon catheter
other name: Impedance balloon testing
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David A Katzka
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: David A. Katzka
investigator title: Principal Investigator
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
sharing ipd: No