<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/NCT03305653</url>
  </required_header>
  <id_info>
    <org_study_id>17-0796</org_study_id>
    <nct_id>NCT03305653</nct_id>
  </id_info>
  <brief_title>Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis</brief_title>
  <official_title>Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      Presently, the only method available to monitor disease activity in Eosinophilic Esophagitis&#xD;
      (EoE) is endoscopy with pathological review of biopsies. The overall goal of this study is to&#xD;
      determine the ability of the Esophageal String Test (EST), a minimally invasive capsule based&#xD;
      technology, to measure disease activity in children with EoE. Additionally, to determine&#xD;
      esophageal distensibility in children presenting with EoE by using the EndoFLIP (functional&#xD;
      luminal imaging probe) device during endoscopic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When children are scheduled to undergo an endoscopy, research assistants will contact the&#xD;
      family to arrange for the Esophageal String Test (EST) to be performed within one week of the&#xD;
      endoscopy. The string test involves swallowing a small capsule with a thin piece of string&#xD;
      inside it. The string unravels as the capsule goes down into the stomach. The investigator&#xD;
      would tape the end of the string to the child's cheek, leaving it there for one hour. At the&#xD;
      end of the hour, the investigator would remove the string by gently pulling it out through&#xD;
      the mouth. Prior to swallowing the EST, the patient will complete the PEESS form (Pediatric&#xD;
      Eosinophilic Esophagitis Symptom Scores) to assess symptoms.&#xD;
&#xD;
      The endoscopy and Endoscopic Reference System (EREFs) and EndoFLIP will be performed. The&#xD;
      EndoFLIP is a slender probe covered by a smooth long balloon that is passed into the&#xD;
      esophagus and slowly expanded with a salt solution. After standard of care endoscopic&#xD;
      visualization, the FLIP, a 16 cm probe (Crospon) will be placed transorally and positioned 3&#xD;
      cm distal to the lower esophageal sphincter. Esophageal cross sectional areas and intrabag&#xD;
      pressure will be measured during stepwise distensions beginning with 5 mL and increasing to a&#xD;
      maximum of 70mL or intrabag pressure of 50 mmHg is achieved, whichever comes first. FLIP is&#xD;
      FDA-approved without age restriction and its use has been approved by our IRBs previously.&#xD;
      Primary results will be reported as distensibility plateau (mm).&#xD;
&#xD;
      Endoscopic severity: Endoscopic esophageal appearances will be scored using a validated EoE&#xD;
      scoring system (EREFS). Five features of EoE will be scored: Edema (0-1), Rings (0-3)&#xD;
      Exudates (0-2), Furrows (0-1), Stricture (0-1). Results will be reported as an inflammatory&#xD;
      score (edema, exudates, furrows) and fibrostenotic score (rings, stricture). Functional&#xD;
      Luminal Imaging Probe (FLIP):&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of Eosinophilic Degranulating Protein Concentration</measure>
    <time_frame>Measurement at one hour, when string is removed</time_frame>
    <description>Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Current/historical diagnosis of EoE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Esophageal String Test (EST)</intervention_name>
    <description>The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.</description>
    <arm_group_label>Current/historical diagnosis of EoE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide signed and dated informed consent form.&#xD;
&#xD;
          -  Willing to comply with all study procedures and be available for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Male or female, aged 7 to 18 years old, inclusive&#xD;
&#xD;
          -  Undergoing upper Endoscopy with biopsy for clinical care at CHCO or CHOP&#xD;
&#xD;
          -  Current or historical diagnosis of EoE, or suspected of having EoE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known connective tissue disease, other eosinophilic disorders&#xD;
&#xD;
          -  Past history of caustic injestion, esophageal surgery or other esophageal injury&#xD;
&#xD;
          -  Known inflammatory bowel disease or esophageal motility disease (achalasia)&#xD;
&#xD;
          -  Unwilling or unable to swallow the EST&#xD;
&#xD;
          -  Oral or intravenous steroids in the preceding 60 days (not including swallowed topical&#xD;
             fluticasone, budesonide, etc)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participation in a clinical study that may interfere with participation in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Calies Menard-Katcher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <results_first_submitted>May 27, 2021</results_first_submitted>
  <results_first_submitted_qc>July 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 6, 2021</results_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03305653/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Current/Historical Diagnosis of EoE</title>
          <description>Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP&#xD;
Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Current/Historical Diagnosis of EoE</title>
          <description>Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP&#xD;
Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Measurement of Eosinophilic Degranulating Protein Concentration</title>
        <description>Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE</description>
        <time_frame>Measurement at one hour, when string is removed</time_frame>
        <population>Number of patients who completed swallowing the string</population>
        <group_list>
          <group group_id="O1">
            <title>Current/Historical Diagnosis of EoE</title>
            <description>Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP&#xD;
Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.</description>
          </group>
        </group_list>
        <measure>
          <title>Measurement of Eosinophilic Degranulating Protein Concentration</title>
          <description>Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE</description>
          <population>Number of patients who completed swallowing the string</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="456.5" lower_limit="6.6" upper_limit="3428.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 72 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Current/Historical Diagnosis of EoE</title>
          <description>Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP&#xD;
Esophageal String Test (EST): The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Calies Menard-Katcher</name_or_title>
      <organization>Children's Hospital Colorado</organization>
      <phone>720-777-2318</phone>
      <email>calies.menard-katcher@childrenscolorado.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03305653
org study id: 17-0796
nct id: NCT03305653
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Presently, the only method available to monitor disease activity in Eosinophilic Esophagitis
      (EoE) is endoscopy with pathological review of biopsies. The overall goal of this study is to
      determine the ability of the Esophageal String Test (EST), a minimally invasive capsule based
      technology, to measure disease activity in children with EoE. Additionally, to determine
      esophageal distensibility in children presenting with EoE by using the EndoFLIP (functional
      luminal imaging probe) device during endoscopic procedures.
When children are scheduled to undergo an endoscopy, research assistants will contact the
      family to arrange for the Esophageal String Test (EST) to be performed within one week of the
      endoscopy. The string test involves swallowing a small capsule with a thin piece of string
      inside it. The string unravels as the capsule goes down into the stomach. The investigator
      would tape the end of the string to the child's cheek, leaving it there for one hour. At the
      end of the hour, the investigator would remove the string by gently pulling it out through
      the mouth. Prior to swallowing the EST, the patient will complete the PEESS form (Pediatric
      Eosinophilic Esophagitis Symptom Scores) to assess symptoms.

      The endoscopy and Endoscopic Reference System (EREFs) and EndoFLIP will be performed. The
      EndoFLIP is a slender probe covered by a smooth long balloon that is passed into the
      esophagus and slowly expanded with a salt solution. After standard of care endoscopic
      visualization, the FLIP, a 16 cm probe (Crospon) will be placed transorally and positioned 3
      cm distal to the lower esophageal sphincter. Esophageal cross sectional areas and intrabag
      pressure will be measured during stepwise distensions beginning with 5 mL and increasing to a
      maximum of 70mL or intrabag pressure of 50 mmHg is achieved, whichever comes first. FLIP is
      FDA-approved without age restriction and its use has been approved by our IRBs previously.
      Primary results will be reported as distensibility plateau (mm).

      Endoscopic severity: Endoscopic esophageal appearances will be scored using a validated EoE
      scoring system (EREFS). Five features of EoE will be scored: Edema (0-1), Rings (0-3)
      Exudates (0-2), Furrows (0-1), Stricture (0-1). Results will be reported as an inflammatory
      score (edema, exudates, furrows) and fibrostenotic score (rings, stricture). Functional
      Luminal Imaging Probe (FLIP):
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Measurement of Eosinophilic Degranulating Protein Concentration
time frame: Measurement at one hour, when string is removed
description: Measure the concentration of eosinophilic degranulating protein on strings that have been swallowed by subjects diagnosed with EoE
arm group label: Current/historical diagnosis of EoE
arm group type: Experimental
description: Subjects with current or historical diagnosis of EoE, or suspected of having EoE will complete the Esophageal String Test (EST) and EndoFLIP
intervention type: Device
intervention name: Esophageal String Test (EST)
description: The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.
arm group label: Current/historical diagnosis of EoE
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Calies Menard-Katcher, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
mesh term: Inflammation
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 