<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/NCT04503785</url>
  </required_header>
  <id_info>
    <org_study_id>1701721848</org_study_id>
    <nct_id>NCT04503785</nct_id>
  </id_info>
  <brief_title>Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring</brief_title>
  <official_title>Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana 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>
      Comparison of manometry measurements and EndoFlip Balloon measurements in patients with&#xD;
      dysphagia and a known esophageal diagnosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia,&#xD;
      difficulty swallowing, is one of the most common issues in gastroenterology. In many&#xD;
      patients, esophageal obstruction is not identified despite workup with upper endoscopy or&#xD;
      barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation&#xD;
      of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test&#xD;
      to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal&#xD;
      Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen&#xD;
      distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently&#xD;
      being used in clinical practice. However, correlation of the results obtained from these&#xD;
      tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the&#xD;
      relationship between esophageal impedance-manometry and EndoFLIP results has never been&#xD;
      defined.&#xD;
&#xD;
      The primary Aim is to develop a registry of patients undergoing esophageal&#xD;
      manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Endoflip parameters for gastroparesis</measure>
    <time_frame>5 years</time_frame>
    <description>Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between endoflip parameters and gastric scintigraphy</measure>
    <time_frame>5 years</time_frame>
    <description>Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between endoflip parameters and symptom severity</measure>
    <time_frame>5 years</time_frame>
    <description>Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Dysphagia, Esophageal</condition>
  <arm_group>
    <arm_group_label>Dysphagia</arm_group_label>
    <description>Patients with Esophageal dysphagia</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Manometry</intervention_name>
    <description>Transnasal Esophageal manometry and Endoflip Balloon distensibility</description>
    <arm_group_label>Dysphagia</arm_group_label>
    <other_name>Endoflip</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study subjects will be recruited from patients who were referred by their physicians to the&#xD;
        GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or&#xD;
        EndoFLIP&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who presented to GI Motility Lab at IU University Hospital for esophageal&#xD;
             manometry-impedance and/or EndoFLIP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 yrs old&#xD;
&#xD;
          -  Unable to communicate verbally with the staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John M Wo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Basil Kahwash, MD</last_name>
    <email>bkahwash@iu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anita Gupta, MBBS</last_name>
    <phone>3179489227</phone>
    <email>anigupta@iu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>March 22, 2018</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>John M. Wo</investigator_full_name>
    <investigator_title>Director of Motility and Neurogastroenterology Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</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/NCT04503785
org study id: 1701721848
nct id: NCT04503785
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of manometry measurements and EndoFlip Balloon measurements in patients with
      dysphagia and a known esophageal diagnosis
Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia,
      difficulty swallowing, is one of the most common issues in gastroenterology. In many
      patients, esophageal obstruction is not identified despite workup with upper endoscopy or
      barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation
      of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test
      to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal
      Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen
      distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently
      being used in clinical practice. However, correlation of the results obtained from these
      tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the
      relationship between esophageal impedance-manometry and EndoFLIP results has never been
      defined.

      The primary Aim is to develop a registry of patients undergoing esophageal
      manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital
observational model: Cohort
time perspective: Other
measure: Endoflip parameters for gastroparesis
time frame: 5 years
description: Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.
measure: Correlation between endoflip parameters and gastric scintigraphy
time frame: 5 years
description: Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis
measure: Correlation between endoflip parameters and symptom severity
time frame: 5 years
description: Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)
arm group label: Dysphagia
description: Patients with Esophageal dysphagia
intervention type: Diagnostic Test
intervention name: Manometry
description: Transnasal Esophageal manometry and Endoflip Balloon distensibility
arm group label: Dysphagia
other name: Endoflip
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John M Wo, MD
role: Principal Investigator
affiliation: Indiana University
last name: Basil Kahwash, MD
email: bkahwash@iu.edu
last name: Anita Gupta, MBBS
phone: 3179489227
email: anigupta@iu.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: John M. Wo
investigator title: Director of Motility and Neurogastroenterology Unit
mesh term: Deglutition Disorders
sharing ipd: No