<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/NCT03829865</url>
  </required_header>
  <id_info>
    <org_study_id>OGIG-2019-1</org_study_id>
    <nct_id>NCT03829865</nct_id>
  </id_info>
  <brief_title>Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry</brief_title>
  <official_title>Chicago Classification Normative Metrics in a Healthy Russian Cohort According to High-resolution Esophageal Manometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Russian Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Russian Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      High resolution esophageal manometry normative values are still need to be studied in&#xD;
      different populations and with the use of solid-state and water-perfused systems. There has&#xD;
      been no study on the subject in healthy Russian population yet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High-resolution esophageal manometry (HREM) is the current modality used to evaluate&#xD;
      esophageal motility. There are 2 types of system: water-perfused system that is cheaper to&#xD;
      maintain and a solid-state system that is considered to be more sensitive. According to the&#xD;
      data obtained in the study of 400 patients and 75 controls by J Pandolfino et al it was&#xD;
      proposed to use a common algorithm of HREM data interpretation and the normative values of&#xD;
      the parameters used to interpret the color plots of HREM. This formed the basis for the first&#xD;
      version of the currently used HREM reporting algorithm and classification of esophageal&#xD;
      motility disorders called Chicago Classification (CC). To date, this classification has been&#xD;
      updated several times by the International Working Group based on the recently published&#xD;
      data. The Working group stated that the proposed normative values still need to be widely&#xD;
      studied for each HREM system and in different populations. Some studies has been published&#xD;
      recently on the normative values of HREM in different countries (predominantly in the US, in&#xD;
      some European countries, Korea, India and China. But there has been no study on the subject&#xD;
      in Russia still.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean IRP</measure>
    <time_frame>mean value of 10 swallows by 30 seconds (about 7 minutes per subject)</time_frame>
    <description>Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean DCI</measure>
    <time_frame>mean value of 10 swallows by 30 seconds (about 7 minutes per subject)</time_frame>
    <description>distal contractile integral - Amplitude x duration x length (mmHg x s x cm) of the distal esophageal contraction exceeding 20 mmHg from the transition zone to the proximal margin of the LES</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean DL</measure>
    <time_frame>mean value of 10 swallows by 30 seconds (about 7 minutes per subject)</time_frame>
    <description>distal latency - Interval between UES relaxation and the contractile deceleration point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean upper esophageal sphincter mean resting pressure</measure>
    <time_frame>mean value based on 30 seconds measurement of a subject</time_frame>
    <description>mean pressure of the upper esophageal sphincter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean lower esophageal sphincter mean resting pressure</measure>
    <time_frame>mean value based on 30 seconds measurement of a subject</time_frame>
    <description>mean pressure of the upper esophageal sphincter</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Water-perfused HREM</arm_group_label>
    <description>Healthy volunteers examined with water-perfused high resolution esophageal manometry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solid-state HREM</arm_group_label>
    <description>Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>High resolution esophageal manometry</intervention_name>
    <description>High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study</description>
    <arm_group_label>Solid-state HREM</arm_group_label>
    <arm_group_label>Water-perfused HREM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study is aimed to evaluate high resolution esophageal motility parameters in subjects&#xD;
        who have no signs of any esophageal disorders and are residents of Russia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (all points are necessary for inclusion):&#xD;
&#xD;
          -  Willingness to participate on the basis of signed informed consent form;&#xD;
&#xD;
          -  Patients of both sexes, aged 18 to 65 years inclusive;&#xD;
&#xD;
          -  Permanent residence in the Russian Federation;&#xD;
&#xD;
          -  Absence of esophageal diseases, confirmed by the results of clinical and instrumental&#xD;
             examination&#xD;
&#xD;
          -  Ability to follow instructions during high-resolution esophageal manometry procedure&#xD;
&#xD;
        Exclusion Criteria (patient is not eligible when at least one exclusion criterion is met):&#xD;
&#xD;
          -  diseases of the esophagus (any condition on the basis of clinical and / or&#xD;
             instrumental examination, including: complaints of heartburn, belching, difficulty to&#xD;
             swallow solid and/or liquid food;&#xD;
&#xD;
          -  any surgical intervention on the gastrointestinal tract and / or chest organs in&#xD;
             medical history;&#xD;
&#xD;
          -  solid organ transplantation in medical history with the exception of a corneal&#xD;
             transplant and surgery to replace the lens of the eye;&#xD;
&#xD;
          -  any oncology of any localization except for skin cancer in situ in the medical&#xD;
             history;&#xD;
&#xD;
          -  any decompensated diseases of any organs and systems, which, in the opinion of the&#xD;
             researcher, makes it impossible to carry out the procedure of esophageal manometry of&#xD;
             high resolution or if the procedure may cause the risk of deterioration of the&#xD;
             patient's condition;&#xD;
&#xD;
          -  any condition, clinical and laboratory signs of alcohol abuse (abuse will be assessed&#xD;
             in the case of male subjects consuming more than 30 g of pure alcohol per day and&#xD;
             using more than 20 g of pure alcohol per day by female subjects;&#xD;
&#xD;
          -  any illegal drug use, current or past;&#xD;
&#xD;
          -  use of concomitant medications that can affect esophageal motility including, but not&#xD;
             limited to: calcium channel blockers, metoclopramide, m-cholinolytics, domperidone,&#xD;
             erythromycin, nitrates, tricyclic antidepressants, opiates, beta-blockers,&#xD;
             beta-adrenomimetics, alcohol. The duration of the period of non-use of these drugs&#xD;
             should provide sufficient time for the complete cessation of their pharmacological&#xD;
             action, but not less than two half-life.&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  any condition making impossible to perform high resolution esophageal manometry&#xD;
             (previously known poor tolerability of the procedure; narrow nasal passages;&#xD;
             significant curvature of the nasal septum etc).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vasily Isakov, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Federal Research Center of Nutrition and Biotechnology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergey Morozov, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Research Center of Nutrition and Biotechnology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sergey Morozov, MD, PhD</last_name>
    <phone>+74996131091</phone>
    <email>morosoffsv@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gastroenterology and Hepatology, FRC Nutrition and Biotechnology</name>
      <address>
        <city>Moscow</city>
        <zip>115446</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergey Morozov, MD, PhD</last_name>
      <phone>+74996131091</phone>
      <email>84996131091@mail.ru</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Moscow clinical hospital #31</name>
      <address>
        <city>Moscow</city>
        <zip>119415</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valeria O Kaibysheva, MD, PhD</last_name>
      <phone>+79160206727</phone>
      <email>valeriakai@mail.ru</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pavlov First Saint Petersburg State Medical University. Endoscopy Department</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandr A Smirnov, MD, PhD</last_name>
      <phone>+78005507225</phone>
      <email>smirnov-1959@yandex.ru</email>
    </contact>
    <contact_backup>
      <last_name>Maya M Kiriltseva, MD, PhD</last_name>
      <phone>+78005507225</phone>
      <email>kiriltseva@mail.ru</email>
    </contact_backup>
    <investigator>
      <last_name>Alexandr A Smirnov, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 22, 2021</last_update_submitted>
  <last_update_submitted_qc>April 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Russian Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Vasily Isakov</investigator_full_name>
    <investigator_title>MD, PhD, Professor, AGAF</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Depersonalized individual data may be shared upon the study completion.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>5 years</ipd_time_frame>
    <ipd_access_criteria>by request</ipd_access_criteria>
  </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/NCT03829865
org study id: OGIG-2019-1
nct id: NCT03829865
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
High resolution esophageal manometry normative values are still need to be studied in
      different populations and with the use of solid-state and water-perfused systems. There has
      been no study on the subject in healthy Russian population yet.
High-resolution esophageal manometry (HREM) is the current modality used to evaluate
      esophageal motility. There are 2 types of system: water-perfused system that is cheaper to
      maintain and a solid-state system that is considered to be more sensitive. According to the
      data obtained in the study of 400 patients and 75 controls by J Pandolfino et al it was
      proposed to use a common algorithm of HREM data interpretation and the normative values of
      the parameters used to interpret the color plots of HREM. This formed the basis for the first
      version of the currently used HREM reporting algorithm and classification of esophageal
      motility disorders called Chicago Classification (CC). To date, this classification has been
      updated several times by the International Working Group based on the recently published
      data. The Working group stated that the proposed normative values still need to be widely
      studied for each HREM system and in different populations. Some studies has been published
      recently on the normative values of HREM in different countries (predominantly in the US, in
      some European countries, Korea, India and China. But there has been no study on the subject
      in Russia still.
observational model: Cohort
time perspective: Prospective
measure: Mean IRP
time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
description: Integrated Relaxation Pressure - mean of the 4 s of maximal deglutitive relaxation in the 10-s window beginning at upper esophageal sphincter relaxation
measure: Mean DCI
time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
description: distal contractile integral - Amplitude x duration x length (mmHg x s x cm) of the distal esophageal contraction exceeding 20 mmHg from the transition zone to the proximal margin of the LES
measure: Mean DL
time frame: mean value of 10 swallows by 30 seconds (about 7 minutes per subject)
description: distal latency - Interval between UES relaxation and the contractile deceleration point
measure: Mean upper esophageal sphincter mean resting pressure
time frame: mean value based on 30 seconds measurement of a subject
description: mean pressure of the upper esophageal sphincter
measure: Mean lower esophageal sphincter mean resting pressure
time frame: mean value based on 30 seconds measurement of a subject
description: mean pressure of the upper esophageal sphincter
arm group label: Water-perfused HREM
description: Healthy volunteers examined with water-perfused high resolution esophageal manometry
arm group label: Solid-state HREM
description: Healthy volunteers examined with high resolution esophageal manometry with solid-state catheter
intervention type: Diagnostic Test
intervention name: High resolution esophageal manometry
description: High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study
arm group label: Solid-state HREM
arm group label: Water-perfused HREM
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vasily Isakov, MD, PhD
role: Study Chair
affiliation: Federal Research Center of Nutrition and Biotechnology
last name: Sergey Morozov, MD, PhD
role: Principal Investigator
affiliation: Federal Research Center of Nutrition and Biotechnology
last name: Sergey Morozov, MD, PhD
phone: +74996131091
email: morosoffsv@mail.ru
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Russian Academy of Medical Sciences
investigator full name: Vasily Isakov
investigator title: MD, PhD, Professor, AGAF
sharing ipd: Yes
ipd description: Depersonalized individual data may be shared upon the study completion.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 5 years
ipd access criteria: by request