xml: <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/NCT05994625</url>
    </required_header>
    <id_info>
      <org_study_id>CLS0007</org_study_id>
      <nct_id>NCT05994625</nct_id>
    </id_info>
    <brief_title>Economic Evaluation of Stream™ Platform</brief_title>
    <acronym>CostAL</acronym>
    <official_title>Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FluidAI Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hamilton Health Sciences Corporation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ontario Bioscience Innovation Organization</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>FluidAI Medical</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional&#xD;
        trial. The purpose of this study is to evaluate the economic and patient outcomes of using&#xD;
        the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal&#xD;
        surgery. The trial will track patient outcomes and healthcare costs in two groups: the&#xD;
        intervention group, where the Stream platform is deployed, and the control group, before the&#xD;
        integration of the Stream™ Platform. The data collected from both groups will be compared to&#xD;
        assess the impact of implementing the Stream™ Platform and early leak detection on overall&#xD;
        patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and&#xD;
        trauma/acute care patient populations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Does Stream™ Platform integrate well with the existing clinical workflow (1)?</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Quantify average time spent by clinical research coordinator (CRC)/delegate interacting with Stream™ Platform (during attachment, daily calibration, and detachment) in minutes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does Stream™ Platform integrate well with the existing clinical workflow (2)?</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Observe overall compliance to Instructions for use though quantification of the number of daily calibrations completed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does Stream™ Platform integrate well with the existing clinical workflow (3)?</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Quantify the overall reported satisfaction score of the CRC/delegate through surveys.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average number of tests and procedures performed to detect anastomotic leakage before and after the implementation of Stream™ Platform.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average patient cost/cost of hospitalization and by-department cost (log of all billed items including medications, laboratory investigations, diagnostic/radiology investigations, hospital length of stay, ICU admission, re-admission within 30 days after discharge, time of discharge and therapeutic services) for colorectal, HPB, and trauma and acute care patients before and after the implementation of Stream™ Platform.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Subjects with Device Related Adverse Events</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (1)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average time to detect anastomotic leakage after colorectal, HPB, and trauma and acute care patients using conventional diagnostic techniques (PRE) and after the implementation of Stream™ Platform (POST).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (2)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average sensitivity, specificity, and overall accuracy of conventional diagnostic techniques for detection of anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries in contrast to the average sensitivity, specificity, and overall accuracy of Stream™ Platform.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (1)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>a. Quantify the average rate of type of re-intervention due to anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (2)?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average number of emergency re-admissions within 30 days after discharge due to anastomotic leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?</measure>
      <time_frame>Upon study completion (12 months)</time_frame>
      <description>Quantify the average number of adverse events (such as rate of secondary postoperative complications, rate of permanent stoma, 30-day mortality, etc.) due to anastomotic leakage after leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">215</enrollment>
    <condition>Anastomotic Leak</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. The continuous pH and electrical conductivity measurements will be used to calculate a Risk Score that will be provided to surgeons. Surgeons will employ the Risk Score produced alongside the standard of care for guiding the postoperative care of patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. However, Stream™ Platform will not generate a Risk Score and therefore, will not impact the postoperative care of patients. All procedures will be conducted as per the standard of care or institutional policies. Stream™ Platform will only be used for observation in the Control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stream™ Platform</intervention_name>
      <description>Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor).&#xD;
  Stream™ Platform utilizes the continuous measurements of drain effluent characteristics to generate a Risk Score that is provided to the surgeon. The Risk Score is intended to provide an additional tool for the early diagnosis of anastomotic leakage.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stream™ Platform with Risk Score Omitted</intervention_name>
      <description>Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor).&#xD;
  This version of Stream™ Platform is utilized purely for observational purposes. Therefore, no Risk Score is generated. This allows postoperative monitoring of patients without any influence from the Stream™ Platform.</description>
      <arm_group_label>Control Group</arm_group_label>
      <other_name>NERv's Inline Device</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years - Male or Female&#xD;
  &#xD;
            -  Subject understands and has voluntarily signed and dated the informed consent form&#xD;
               (ICF).&#xD;
  &#xD;
            -  Subjects must be willing to comply with trial requirements&#xD;
  &#xD;
            -  Subject has performed an open or laparoscopic surgery with peritoneal or pelvic&#xD;
               drainage&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject is pregnant&#xD;
  &#xD;
            -  Subject will be discharged &lt; 8 hours post-surgery&#xD;
  &#xD;
            -  24 or more have passed since the end of the subject's surgery&#xD;
  &#xD;
            -  Involvement in the planning and conduct of the clinical investigation&#xD;
  &#xD;
            -  Subject is allergic to contrast medium&#xD;
  &#xD;
            -  Participation in another investigational drug or device study which would interfere&#xD;
               with the endpoints of this study&#xD;
  &#xD;
            -  Device does not attach to drain used on the subject&#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_contact>
      <last_name>Dr. Pablo E Serrano, MD, MPH, FACS</last_name>
      <phone>(905) 521-2100</phone>
      <phone_ext>43872</phone_ext>
      <email>serrano@mcmaster.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hamilton General Hospital - Hamilton Health Sciences</name>
        <address>
          <city>Hamilton</city>
          <state>Ontario</state>
          <zip>L8L 2X2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Edward Passos, MD, FRCSC</last_name>
        <phone>905-521-2100</phone>
        <phone_ext>44237</phone_ext>
        <email>passosem@mcmaster.ca</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Juravinski Hospital- Hamilton Health Sciences</name>
        <address>
          <city>Hamilton</city>
          <state>Ontrario</state>
          <zip>L8V 1C3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Pablo E Serrano, MD, MPH, FACS</last_name>
        <phone>(905) 521-2100</phone>
        <phone_ext>43872</phone_ext>
        <email>serrano@mcmaster.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</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>Anastomotic Leak</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994625
  org study id: CLS0007
  nct id: NCT05994625
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional
        trial. The purpose of this study is to evaluate the economic and patient outcomes of using
        the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal
        surgery. The trial will track patient outcomes and healthcare costs in two groups: the
        intervention group, where the Stream platform is deployed, and the control group, before the
        integration of the Stream™ Platform. The data collected from both groups will be compared to
        assess the impact of implementing the Stream™ Platform and early leak detection on overall
        patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and
        trauma/acute care patient populations.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Does Stream™ Platform integrate well with the existing clinical workflow (1)?
  time frame: Through study completion, an average of 1 year
  description: Quantify average time spent by clinical research coordinator (CRC)/delegate interacting with Stream™ Platform (during attachment, daily calibration, and detachment) in minutes
  measure: Does Stream™ Platform integrate well with the existing clinical workflow (2)?
  time frame: Through study completion, an average of 1 year
  description: Observe overall compliance to Instructions for use though quantification of the number of daily calibrations completed
  measure: Does Stream™ Platform integrate well with the existing clinical workflow (3)?
  time frame: Through study completion, an average of 1 year
  description: Quantify the overall reported satisfaction score of the CRC/delegate through surveys.
  measure: Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)?
  time frame: Upon study completion (12 months)
  description: Quantify the average number of tests and procedures performed to detect anastomotic leakage before and after the implementation of Stream™ Platform.
  measure: Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)?
  time frame: Upon study completion (12 months)
  description: Quantify the average patient cost/cost of hospitalization and by-department cost (log of all billed items including medications, laboratory investigations, diagnostic/radiology investigations, hospital length of stay, ICU admission, re-admission within 30 days after discharge, time of discharge and therapeutic services) for colorectal, HPB, and trauma and acute care patients before and after the implementation of Stream™ Platform.
  measure: Number of Subjects with Device Related Adverse Events
  time frame: Upon study completion (12 months)
  description: An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
  measure: Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (1)?
  time frame: Upon study completion (12 months)
  description: Quantify the average time to detect anastomotic leakage after colorectal, HPB, and trauma and acute care patients using conventional diagnostic techniques (PRE) and after the implementation of Stream™ Platform (POST).
  measure: Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (2)?
  time frame: Upon study completion (12 months)
  description: Quantify the average sensitivity, specificity, and overall accuracy of conventional diagnostic techniques for detection of anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries in contrast to the average sensitivity, specificity, and overall accuracy of Stream™ Platform.
  measure: Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (1)?
  time frame: Upon study completion (12 months)
  description: a. Quantify the average rate of type of re-intervention due to anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.
  measure: Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (2)?
  time frame: Upon study completion (12 months)
  description: Quantify the average number of emergency re-admissions within 30 days after discharge due to anastomotic leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.
  measure: Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?
  time frame: Upon study completion (12 months)
  description: Quantify the average number of adverse events (such as rate of secondary postoperative complications, rate of permanent stoma, 30-day mortality, etc.) due to anastomotic leakage after leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. The continuous pH and electrical conductivity measurements will be used to calculate a Risk Score that will be provided to surgeons. Surgeons will employ the Risk Score produced alongside the standard of care for guiding the postoperative care of patients.
  arm group label: Control Group
  arm group type: Sham Comparator
  description: Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. However, Stream™ Platform will not generate a Risk Score and therefore, will not impact the postoperative care of patients. All procedures will be conducted as per the standard of care or institutional policies. Stream™ Platform will only be used for observation in the Control group.
  intervention type: Device
  intervention name: Stream™ Platform
  description: Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor).
  Stream™ Platform utilizes the continuous measurements of drain effluent characteristics to generate a Risk Score that is provided to the surgeon. The Risk Score is intended to provide an additional tool for the early diagnosis of anastomotic leakage.
  arm group label: Intervention Group
  intervention type: Device
  intervention name: Stream™ Platform with Risk Score Omitted
  description: Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor).
  This version of Stream™ Platform is utilized purely for observational purposes. Therefore, no Risk Score is generated. This allows postoperative monitoring of patients without any influence from the Stream™ Platform.
  arm group label: Control Group
  other name: NERv's Inline Device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dr. Pablo E Serrano, MD, MPH, FACS
  phone: (905) 521-2100
  phone ext: 43872
  email: serrano@mcmaster.ca
  facility: 
  contact: 
  facility: 
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Anastomotic Leak
  sharing ipd: No