<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/NCT04419220</url>
  </required_header>
  <id_info>
    <org_study_id>CCP19-3306-DUS</org_study_id>
    <nct_id>NCT04419220</nct_id>
  </id_info>
  <brief_title>Reproducibility of Flow Measurements in the SMA Using Doppler Ultrasound</brief_title>
  <official_title>Evaluating Reproducibility of Flow Measurements in the Superior Mesenteric Artery in Healthy Male Subjects Using Doppler Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a single center, methodological study in healthy male subjects to evaluate the&#xD;
      intra-period, inter-period and inter-observer reproducibility of flow measurements in the&#xD;
      superior mesenteric artery, using Doppler Ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center, methodological study in healthy male subjects, aged 18-50, to&#xD;
      evaluate the intra-period, inter-period and inter-observer reproducibility of flow&#xD;
      measurements in the superior mesenteric artery, using Doppler Ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Actual">July 4, 2019</completion_date>
  <primary_completion_date type="Actual">July 4, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-period reproducibility of flow measurements</measure>
    <time_frame>Interval of 30 minutes between two measurements during study visit 1</time_frame>
    <description>Reproducibility of flow measurements performed during study visit 1 by the same observer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra-period reproducibility of flow measurements</measure>
    <time_frame>Interval of 30 minutes between two measurements during study visit 2</time_frame>
    <description>Reproducibility of flow measurements performed during study visit 2 by the same observer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-period reproducibility of flow measurements</measure>
    <time_frame>Interval of at least 3 days between both study visits</time_frame>
    <description>Reproducibility (i.e. assessing changes) of flow measurements performed during two separate study visits by the same observer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-observer reproducibility of flow measurements</measure>
    <time_frame>Interval of 15 minutes between two measurements during study visit1</time_frame>
    <description>Reproducibility of flow measurements performed during study visit 1 by two different observers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-observer reproducibility of flow measurements</measure>
    <time_frame>Interval of 15 minutes between two measurements during study visit 2</time_frame>
    <description>Reproducibility of flow measurements performed during study visit 2 by two different observers.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>Doppler Ultrasound will be performed in all subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Doppler Ultrasound</intervention_name>
    <description>Flow measurements using Doppler ultrasound</description>
    <arm_group_label>Observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy male volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is a male ≥18 and ≤ 50 years of age.&#xD;
&#xD;
          -  Subject is a non-smoker for at least 6 months prior to study start.&#xD;
&#xD;
          -  Subject has a body mass index between 18-28 kg/m2.&#xD;
&#xD;
          -  Subject is judged to be in good health on the basis of medical history and vital&#xD;
             signs.&#xD;
&#xD;
          -  Subject understands the procedures and agrees to participate in the study by giving&#xD;
             written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of any illness which, in the investigator's opinion, might&#xD;
             confound the results of the study.&#xD;
&#xD;
          -  Subject has burns, scars, flaps or grafts on the abdomen which, in the investigator's&#xD;
             opinion, may interfere with the study assessments.&#xD;
&#xD;
          -  Subject has an anatomical anomaly of the SMA as evaluated with DUS during screening&#xD;
             which, in the investigator's opinion, may interfere with the study assessments.&#xD;
&#xD;
          -  Subject currently uses any prescription or non-prescription drugs on a regular basis&#xD;
             which, in the investigator's opinion, might confound the results of the study. Subject&#xD;
             has taken 7 days prior to the start of the study any prescription or non-prescription&#xD;
             drugs which, in the investigator's opinion, might confound the results of the study.&#xD;
&#xD;
          -  Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit&#xD;
             or has a history of drug (including alcohol) abuse.&#xD;
&#xD;
          -  Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea,&#xD;
             cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake&#xD;
             of caffeinated beverages to ≤4 cups a day throughout the study.&#xD;
&#xD;
          -  Subject has any of the following vital sign measurements at screening: Heart Rate &lt;40&#xD;
             or &gt;100 beats/min, Diastolic Blood Pressure &lt;50 or &gt;90 mmHg, Systolic Blood Pressure&#xD;
             &lt;90 or &gt;140 mmHg.&#xD;
&#xD;
          -  Subject has been involved in testing an investigational drug in another clinical study&#xD;
             within the last 4 weeks.&#xD;
&#xD;
          -  Subject is in a situation or has a condition which, in the opinion of the&#xD;
             investigator, may interfere with optimal participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Clinical Pharmacology</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 6, 2019</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04419220
org study id: CCP19-3306-DUS
nct id: NCT04419220
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This will be a single center, methodological study in healthy male subjects to evaluate the
      intra-period, inter-period and inter-observer reproducibility of flow measurements in the
      superior mesenteric artery, using Doppler Ultrasound.
This will be a single center, methodological study in healthy male subjects, aged 18-50, to
      evaluate the intra-period, inter-period and inter-observer reproducibility of flow
      measurements in the superior mesenteric artery, using Doppler Ultrasound.
observational model: Other
time perspective: Prospective
measure: Intra-period reproducibility of flow measurements
time frame: Interval of 30 minutes between two measurements during study visit 1
description: Reproducibility of flow measurements performed during study visit 1 by the same observer.
measure: Intra-period reproducibility of flow measurements
time frame: Interval of 30 minutes between two measurements during study visit 2
description: Reproducibility of flow measurements performed during study visit 2 by the same observer.
measure: Inter-period reproducibility of flow measurements
time frame: Interval of at least 3 days between both study visits
description: Reproducibility (i.e. assessing changes) of flow measurements performed during two separate study visits by the same observer
measure: Inter-observer reproducibility of flow measurements
time frame: Interval of 15 minutes between two measurements during study visit1
description: Reproducibility of flow measurements performed during study visit 1 by two different observers.
measure: Inter-observer reproducibility of flow measurements
time frame: Interval of 15 minutes between two measurements during study visit 2
description: Reproducibility of flow measurements performed during study visit 2 by two different observers.
arm group label: Observational
description: Doppler Ultrasound will be performed in all subjects.
intervention type: Other
intervention name: Doppler Ultrasound
description: Flow measurements using Doppler ultrasound
arm group label: Observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor