<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/NCT02195713</url>
  </required_header>
  <id_info>
    <org_study_id>PM-JMSRF2014-BCF01</org_study_id>
    <nct_id>NCT02195713</nct_id>
  </id_info>
  <brief_title>Evaluation of a Novel Electronic Urine Output Monitor (eUOM)</brief_title>
  <official_title>Evaluation of a Novel Electronic Urine Output Monitor (eUOM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Potrero Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Potrero Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urine output and urine drain line pressure were monitored while urine was drained into&#xD;
      either:&#xD;
&#xD;
        1. Accuryn Urine Output Monitor (Potrero Medical) OR&#xD;
&#xD;
        2. Criticore Monitor (Bard Medical)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the characteristics of urine output and drain line&#xD;
      pressure as measured with the Accuryn urinary output monitoring system and urine output as&#xD;
      recorded by a commercially available system (Criticore, Bard Medical) when used with a&#xD;
      standard Foley catheter and standard urinary drainage tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Urine Output of SOC Device Versus Accuryn</measure>
    <time_frame>2 - 5 days</time_frame>
    <description>Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Oliguria</condition>
  <condition>Polyuria</condition>
  <arm_group>
    <arm_group_label>Test- Accuryn Urine Output Monitor</arm_group_label>
    <description>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control- Critcore Urine Output Monitor</arm_group_label>
    <description>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accuryn</intervention_name>
    <description>Accuryn is a novel electronic urine output monitor</description>
    <arm_group_label>Test- Accuryn Urine Output Monitor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patient that needs a Foley catheter&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must ≥ 18 years of age&#xD;
&#xD;
          -  Patient has a Foley catheter and urine collection system is in place per standard&#xD;
             clinical decision&#xD;
&#xD;
          -  Estimated length of placement of the Foley is 48 hours minimum&#xD;
&#xD;
          -  Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)&#xD;
&#xD;
          -  Subject or subject's legally authorized representative is able to give informed&#xD;
             consent before entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or breastfeeding&#xD;
&#xD;
          -  Clinical signs or symptoms of a urinary tract infection (UTI)&#xD;
&#xD;
          -  Clinical signs or symptoms of a vaginal infection&#xD;
&#xD;
          -  Currently has bladder or urethral trauma&#xD;
&#xD;
          -  Use of investigational drug/device therapy within the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Kramer</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruce Friedman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joseph M. Stills Burn Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joseph M. Still Burn Center at Doctors Hospital</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Medical Branch (UTMBP)</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://potreromed.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>August 3, 2015</results_first_submitted>
  <results_first_submitted_qc>August 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 1, 2015</results_first_posted>
  <last_update_submitted>January 20, 2016</last_update_submitted>
  <last_update_submitted_qc>January 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyuria</mesh_term>
    <mesh_term>Oliguria</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test- Accuryn Urine Output Monitor</title>
          <description>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.&#xD;
Accuryn: Accuryn is a novel electronic urine output monitor</description>
        </group>
        <group group_id="P2">
          <title>Control- Critcore Urine Output Monitor</title>
          <description>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test- Accuryn Urine Output Monitor</title>
          <description>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.&#xD;
Accuryn: Accuryn is a novel electronic urine output monitor</description>
        </group>
        <group group_id="B2">
          <title>Control- Critcore Urine Output Monitor</title>
          <description>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" spread="22"/>
                    <measurement group_id="B2" value="52" spread="17.9"/>
                    <measurement group_id="B3" value="49" spread="20.2"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </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="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Urine Output of SOC Device Versus Accuryn</title>
        <description>Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.</description>
        <time_frame>2 - 5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test- Accuryn Urine Output Monitor</title>
            <description>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.&#xD;
Accuryn: Accuryn is a novel electronic urine output monitor</description>
          </group>
          <group group_id="O2">
            <title>Control- Critcore Urine Output Monitor</title>
            <description>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Output of SOC Device Versus Accuryn</title>
          <description>Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.</description>
          <units>Patients with airlocks</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="5" lower_limit="5" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Test- Accuryn Urine Output Monitor</title>
          <description>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.&#xD;
Accuryn: Accuryn is a novel electronic urine output monitor</description>
        </group>
        <group group_id="E2">
          <title>Control- Critcore Urine Output Monitor</title>
          <description>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Devyani Nanduri</name_or_title>
      <organization>Theranova, LLC</organization>
      <phone>415-926-8616</phone>
      <email>dnanduri@theranova.com</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/NCT02195713
org study id: PM-JMSRF2014-BCF01
nct id: NCT02195713
lead sponsor: 
has dmc: Yes
Urine output and urine drain line pressure were monitored while urine was drained into
      either:

        1. Accuryn Urine Output Monitor (Potrero Medical) OR

        2. Criticore Monitor (Bard Medical)
The purpose of this study is to determine the characteristics of urine output and drain line
      pressure as measured with the Accuryn urinary output monitoring system and urine output as
      recorded by a commercially available system (Criticore, Bard Medical) when used with a
      standard Foley catheter and standard urinary drainage tube.
observational model: Cohort
time perspective: Prospective
measure: Urine Output of SOC Device Versus Accuryn
time frame: 2 - 5 days
description: Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.
arm group label: Test- Accuryn Urine Output Monitor
description: Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
arm group label: Control- Critcore Urine Output Monitor
description: A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
intervention type: Device
intervention name: Accuryn
description: Accuryn is a novel electronic urine output monitor
arm group label: Test- Accuryn Urine Output Monitor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Kramer
role: Principal Investigator
affiliation: UTMB
last name: Bruce Friedman
role: Principal Investigator
affiliation: Joseph M. Stills Burn Center
facility: 
facility: 
country: United States
url: http://potreromed.com
description: Related Info
responsible party type: Sponsor
mesh term: Polyuria
mesh term: Oliguria
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 