<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/NCT03817281</url>
  </required_header>
  <id_info>
    <org_study_id>CRD-06-100473</org_study_id>
    <nct_id>NCT03817281</nct_id>
  </id_info>
  <brief_title>Collective Accuryn Physiologic Signals and Signatures</brief_title>
  <acronym>CAPSS</acronym>
  <official_title>Collective Accuryn Physiologic Signals and Signatures: A Retrospective and Prospective Analysis (CAPSS Study)</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>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>
      The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data&#xD;
      collection study with an FDA cleared device. Physiologic data measurements will be collected&#xD;
      from enrolled subjects using electronic health records and data streams via the Accuryn&#xD;
      Monitoring System. Analysis of these data has the potential to be able to acutely guide&#xD;
      resuscitation and monitor trends for emerging critical conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the CAPSS Study is to track and analyze changes in physiologic data&#xD;
      streams to identify clinical signatures that may enable earlier diagnosis of, and effective&#xD;
      intervention in, critical conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of Enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">March 29, 2020</start_date>
  <completion_date type="Actual">March 29, 2020</completion_date>
  <primary_completion_date type="Actual">March 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Physiologic Changes</measure>
    <time_frame>30 days</time_frame>
    <description>Track and analyze changes in physiologic data streams captured using the Accuryn Monitoring System to identify clinical signatures that may enable earlier diagnosis and effective intervention of critical conditions. Potential examples include AKI, sepsis/septic shock, ACS, and optimization of fluid resuscitation.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Critical Illness</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <condition>Abdominal Compartment Syndrome</condition>
  <arm_group>
    <arm_group_label>Accuryn Monitoring System</arm_group_label>
    <description>Observational only (no intervention). Study Cohort is patients using the Accuryn Monitoring System as a standard-of-care digital urimeter, during their standard course of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accuryn Monitoring System</intervention_name>
    <description>The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.</description>
    <arm_group_label>Accuryn Monitoring System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will comprise patients from high acuity centers such as burn, trauma,&#xD;
        surgical, and critical care units.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Received Accuryn Monitoring System during hospital stay.&#xD;
&#xD;
          2. Diagnosed with or developed one or more of the targeted conditions while connected to&#xD;
             the Accuryn Monitoring System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. In the opinion of the investigator, the patient is unsuitable for the study.&#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>Eileen M Bulger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington Harborview</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</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>Compartment Syndromes</mesh_term>
    <mesh_term>Intra-Abdominal Hypertension</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03817281
org study id: CRD-06-100473
nct id: NCT03817281
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data
      collection study with an FDA cleared device. Physiologic data measurements will be collected
      from enrolled subjects using electronic health records and data streams via the Accuryn
      Monitoring System. Analysis of these data has the potential to be able to acutely guide
      resuscitation and monitor trends for emerging critical conditions.
The primary objective of the CAPSS Study is to track and analyze changes in physiologic data
      streams to identify clinical signatures that may enable earlier diagnosis of, and effective
      intervention in, critical conditions.
observational model: Case-Only
time perspective: Prospective
measure: Physiologic Changes
time frame: 30 days
description: Track and analyze changes in physiologic data streams captured using the Accuryn Monitoring System to identify clinical signatures that may enable earlier diagnosis and effective intervention of critical conditions. Potential examples include AKI, sepsis/septic shock, ACS, and optimization of fluid resuscitation.
arm group label: Accuryn Monitoring System
description: Observational only (no intervention). Study Cohort is patients using the Accuryn Monitoring System as a standard-of-care digital urimeter, during their standard course of treatment.
intervention type: Device
intervention name: Accuryn Monitoring System
description: The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
arm group label: Accuryn Monitoring System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eileen M Bulger, MD
role: Principal Investigator
affiliation: University of Washington Harborview
facility: 
country: United States
responsible party type: Sponsor
mesh term: Compartment Syndromes
mesh term: Intra-Abdominal Hypertension
mesh term: Acute Kidney Injury
mesh term: Critical Illness
sharing ipd: Undecided