<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/NCT03831724</url>
  </required_header>
  <id_info>
    <org_study_id>MDT18047</org_study_id>
    <nct_id>NCT03831724</nct_id>
  </id_info>
  <brief_title>Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects</brief_title>
  <acronym>RUBY</acronym>
  <official_title>Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects (&quot;RUBY Study&quot;)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data&#xD;
      of EGJ-distensibility measurements and contractile patterns in healthy subjects.&#xD;
&#xD;
      Asymptomatic subjects will be enrolled at up to 7 clinical sites in the United States.&#xD;
&#xD;
      Subjects who meet inclusion and no exclusion criteria and are deemed asymptomatic will be&#xD;
      eligible for study enrollment.&#xD;
&#xD;
      The procedure visit/s will consist of the following procedures: High resolution manometry&#xD;
      (HRM), esophagogastroduodenoscopy (EGD), endolumenal functional lumen imaging probe&#xD;
      (EndoFLIP) and a Bravo procedure.&#xD;
&#xD;
      A post procedure follow-up phone call will be conducted within 5-9 days of completing all&#xD;
      procedures.&#xD;
&#xD;
      HRM, EGD, and Bravo procedures are performed to evaluate subjects as normal in addition to&#xD;
      being asymptomatic. Abnormal results in one or more of the procedures identifies the subject&#xD;
      as unhealthy and the subject will be withdrawn from the study.&#xD;
&#xD;
      The expected duration of subject's participation in the study is up to 70 days (up to 30 days&#xD;
      from screening to HRM, up to 30 days to complete EGD, EndoFLIP and Bravo, plus 5-9 days for&#xD;
      follow up call).&#xD;
&#xD;
      Enrollment duration - up to 1 year&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Company decision to withdraw the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2019</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects</measure>
    <time_frame>70 days</time_frame>
    <description>Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject</measure>
    <time_frame>70 days</time_frame>
    <description>Mean and median EGJ-DI at different balloon fill volumes of the same subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject</measure>
    <time_frame>70 days</time_frame>
    <description>Mean and median maximum restrictive EGJ diameter at different balloon fill volumes of the same subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject</measure>
    <time_frame>70 days</time_frame>
    <description>Mean and median distal esophageal body diameter at different balloon fill volumes of the same subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject</measure>
    <time_frame>70 days</time_frame>
    <description>Presence of Repetitive antegrade contractions (RACs) and number of antegrade contractions at different balloon fill volumes of the same subject&#xD;
Presence of Repetitive Retrograde Contractions (RRCs) and number of retrograde contractions at different balloon fill volumes of the same subject</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>EndoFLIP™ System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EndoFLIP™ System with FLIP Topography Module</intervention_name>
    <description>The EndoFLIP system with the EF-322N catheter will be used. The EndoFLIP system is a tool that assesses esophageal, esophago-gastric junction (EGJ)/lower esophageal sphincter (LES), and pylorus function. It allows the measurement of LES and pylorus distensibility as well as esophageal contractile activity in response to distension. The system uses impedance planimetry to measure luminal cross-sectional area (CSA) along an axial plane during volume-controlled distention.</description>
    <arm_group_label>EndoFLIP™ System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female ages 18-75 years.&#xD;
&#xD;
          2. The subject has the ability to give informed consent.&#xD;
&#xD;
          3. The subject has the ability to undergo sedation, as assessed and determined by the&#xD;
             treating physician or the anesthesiologist.&#xD;
&#xD;
          4. BMI range of 18-30 kg/m2.&#xD;
&#xD;
          5. Asymptomatic subjects as assessed by gastro-esophageal reflux disease questionnaire&#xD;
             (GERDQ) negative score of less than 8 points (GERDQ &lt;8) and brief esophageal dysphagia&#xD;
             questionnaire (BEDQ) negative score of 0 points (BEDQ score=0), as assessed and&#xD;
             determined by treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has known or suspected major gastrointestinal motility disorders including but&#xD;
             not limited to major esophageal motility disorders, EGJ outflow obstruction and&#xD;
             delayed gastric emptying.&#xD;
&#xD;
          2. Subject has dysphagia or any swallowing disorder.&#xD;
&#xD;
          3. Subject has an inability to tolerate nasal intubation.&#xD;
&#xD;
          4. Subject has a known or suspected bleeding diathesis.&#xD;
&#xD;
          5. Subject with known or suspected Gastroesophageal Reflux Disease (GERD), or subject has&#xD;
             symptoms of GERD.&#xD;
&#xD;
          6. The subject has a known or suspected esophageal disease or disorder such as&#xD;
             eosinophilic esophagitis (EOE), Barretts esophagus, severe esophagitis, upper GI&#xD;
             bleeding or esophageal varices.&#xD;
&#xD;
          7. Subject is known or is suspected to suffer from an esophageal stricture or&#xD;
             obstruction.&#xD;
&#xD;
          8. Subject has a hiatal hernia.&#xD;
&#xD;
          9. Subject with medical comorbidities such as diabetes, hypertension&#xD;
             hyper/hypothyroidism, or chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
         10. Subject with a diagnosed autoimmune disease.&#xD;
&#xD;
         11. Subject who has undergone prior upper GI surgery or interventions such as esophageal&#xD;
             myotomy, fundoplication, dilatation or stent.&#xD;
&#xD;
         12. Subject has a history of any malignancy.&#xD;
&#xD;
         13. Subject has a history of any seizure disorder.&#xD;
&#xD;
         14. Subject has a history of an eating disorder/s.&#xD;
&#xD;
         15. Subject has an active history of nicotine use, cannabis use or alcohol abuse (as&#xD;
             defined by: greater than 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3&#xD;
             drinks/day for women. A standard drink is defined as 12 oz of beer, 5 oz of wine, or&#xD;
             1.5 oz of liquor). Subject has used any tobacco, nicotine or cannabis products in the&#xD;
             last 6 months or has abused alcohol in the last 6 months.&#xD;
&#xD;
         16. Subject taking or prescribed or over-the-counter any acid suppressant medications (for&#xD;
             example proton-pump inhibitors), any medication that treats reflux or heartburn&#xD;
             symptoms (for example Tums and Maalox), any anticoagulant medications, any opiate&#xD;
             medication or medication with known impact on GI motility.&#xD;
&#xD;
         17. Subject has any allergy or other contraindication to the device components or to study&#xD;
             medication used prior and/or during the procedure.&#xD;
&#xD;
         18. Subject has a known sensitivity or allergy to nickel or other heavy metals.&#xD;
&#xD;
         19. Subject has any condition, which according to the investigators judgment, precludes&#xD;
             compliance with study and/or device instructions.&#xD;
&#xD;
         20. Females who are pregnant or nursing at the time of screening and/or during the study&#xD;
             period or are sexually active and of child bearing potential without medically&#xD;
             acceptable methods of contraception.&#xD;
&#xD;
         21. Subject who has a cardiac pacemaker or implantable cardiac defibrillator.&#xD;
&#xD;
         22. Subject who has a general contraindication for upper endoscopy.&#xD;
&#xD;
         23. Subject who is currently participating in another clinical study (investigational drug&#xD;
             or device).&#xD;
&#xD;
         24. Subject who is considered to be part of a vulnerable population (e.g. prisoners or&#xD;
             those without sufficient mental capacity).&#xD;
&#xD;
         25. Medtronic employees.&#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>Rena Yadlapati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>November 17, 2019</last_update_submitted>
  <last_update_submitted_qc>November 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03831724
org study id: MDT18047
nct id: NCT03831724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data
      of EGJ-distensibility measurements and contractile patterns in healthy subjects.

      Asymptomatic subjects will be enrolled at up to 7 clinical sites in the United States.

      Subjects who meet inclusion and no exclusion criteria and are deemed asymptomatic will be
      eligible for study enrollment.

      The procedure visit/s will consist of the following procedures: High resolution manometry
      (HRM), esophagogastroduodenoscopy (EGD), endolumenal functional lumen imaging probe
      (EndoFLIP) and a Bravo procedure.

      A post procedure follow-up phone call will be conducted within 5-9 days of completing all
      procedures.

      HRM, EGD, and Bravo procedures are performed to evaluate subjects as normal in addition to
      being asymptomatic. Abnormal results in one or more of the procedures identifies the subject
      as unhealthy and the subject will be withdrawn from the study.

      The expected duration of subject's participation in the study is up to 70 days (up to 30 days
      from screening to HRM, up to 30 days to complete EGD, EndoFLIP and Bravo, plus 5-9 days for
      follow up call).

      Enrollment duration - up to 1 year
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects
time frame: 70 days
description: Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume
measure: To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject
time frame: 70 days
description: Mean and median EGJ-DI at different balloon fill volumes of the same subject
measure: To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject
time frame: 70 days
description: Mean and median maximum restrictive EGJ diameter at different balloon fill volumes of the same subject
measure: To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject
time frame: 70 days
description: Mean and median distal esophageal body diameter at different balloon fill volumes of the same subject
measure: To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject
time frame: 70 days
description: Presence of Repetitive antegrade contractions (RACs) and number of antegrade contractions at different balloon fill volumes of the same subject
Presence of Repetitive Retrograde Contractions (RRCs) and number of retrograde contractions at different balloon fill volumes of the same subject
arm group label: EndoFLIP™ System
arm group type: Experimental
description: Device interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo
intervention type: Device
intervention name: EndoFLIP™ System with FLIP Topography Module
description: The EndoFLIP system with the EF-322N catheter will be used. The EndoFLIP system is a tool that assesses esophageal, esophago-gastric junction (EGJ)/lower esophageal sphincter (LES), and pylorus function. It allows the measurement of LES and pylorus distensibility as well as esophageal contractile activity in response to distension. The system uses impedance planimetry to measure luminal cross-sectional area (CSA) along an axial plane during volume-controlled distention.
arm group label: EndoFLIP™ System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rena Yadlapati, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor
sharing ipd: No