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/NCT05990660</url>
    </required_header>
    <id_info>
      <org_study_id>RAD1117-01</org_study_id>
      <nct_id>NCT05990660</nct_id>
    </id_info>
    <brief_title>Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery</brief_title>
    <acronym>BIPASS-AKI</acronym>
    <official_title>Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>3ive Labs</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>SCIRENT</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>3ive Labs</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_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is a prospective, non-randomized early feasibility study intended to evaluate the&#xD;
        safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist&#xD;
        Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing&#xD;
        cardiac surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of&#xD;
        developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently,&#xD;
        overall poor outcomes. Patients to be considered for participation include those undergoing&#xD;
        elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft,&#xD;
        valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a&#xD;
        pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion&#xD;
        criteria will be enrolled into a treatment arm (single-arm study) following the completion of&#xD;
        informed consent. Participants will receive implantation of the JuxtaFlow Catheters following&#xD;
        completion of the their cardiac surgery while remaining under anesthesia. Treatment with the&#xD;
        JuxtaFlow System will be initiated upon the participant's arrival into the intensive care&#xD;
        unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and&#xD;
        post-operative data will be collected on participants to include 15- and 30-day follow-up&#xD;
        periods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 4, 2023</start_date>
    <completion_date type="Anticipated">March 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 4, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>[Safety] Adverse Events Characterization</measure>
      <time_frame>30 days</time_frame>
      <description>The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>[Efficacy] Creatinine Clearance</measure>
      <time_frame>24 hours</time_frame>
      <description>The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>[Efficacy] Urine Sodium Excretion</measure>
      <time_frame>24 hours</time_frame>
      <description>The change in urine sodium excretion occurring over the treatment period of 24 hours or less.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Renal Insufficiency</condition>
    <condition>Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>JuxtaFlow System</intervention_name>
      <description>Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Candidate cardiac surgical patients&#xD;
  &#xD;
            2. Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular&#xD;
               surgery&#xD;
  &#xD;
            3. Age 22 to 85 years&#xD;
  &#xD;
            4. eGFR &lt; 60 mL/min/1.73m2&#xD;
  &#xD;
            5. Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. End-stage renal disease (receiving hemodialysis or glomerular filtration rate &lt;15&#xD;
               ml/min/1.73m2)&#xD;
  &#xD;
            2. Planned off-pump surgery&#xD;
  &#xD;
            3. Any patients with high-grade proteinuria (i.e., urine protein concentration &gt; 300&#xD;
               mg/dL)&#xD;
  &#xD;
            4. Pregnancy&#xD;
  &#xD;
            5. Any secondary condition as determined by the investigator that would place the subject&#xD;
               at an increased risk, or preclude the subject's full compliance with the study&#xD;
               procedures, including injuries to the urinary organs and/or external genitals&#xD;
  &#xD;
            6. Current or planned treatment with an investigational drug (IND), device (IDE), or&#xD;
               other investigational intervention within 3 months prior to or during participation in&#xD;
               this clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Slobodan Micovic, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute for Cardiovascular Diseases &quot;Dedinje&quot;</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Milovan Petrovic, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Cardiovascular Diseases of Vojvodina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lance M Black, MD</last_name>
      <phone>(850) 218-5259</phone>
      <email>lance.black@3ivelabs.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bryan Tucker, PhD</last_name>
      <phone>(919) 942-4511</phone>
      <email>bryan.tucker@3ivelabs.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institute for Cardiovascular Diseases &quot;Dedinje&quot;</name>
        <address>
          <city>Belgrade</city>
          <country>Serbia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nataša Panić</last_name>
        <phone>+381 63 1287 582</phone>
        <email>natasa.panic@scirent.com</email>
      </contact>
      <contact_backup>
        <last_name>Nenad Milošević</last_name>
        <phone>+381 62 287 082</phone>
        <email>nenad.milosevic@scirent.com</email>
      </contact_backup>
      <investigator>
        <last_name>Slobodan Micovic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institute of Cardiovascular Diseases of Vojvodina</name>
        <address>
          <city>Sremska Kamenica</city>
          <country>Serbia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Nataša Panić</last_name>
        <phone>+381 63 1287 582</phone>
        <email>natasa.panic@scirent.com</email>
      </contact>
      <contact_backup>
        <last_name>Nenad Milošević</last_name>
        <phone>+381 62 287 082</phone>
        <email>nenad.milosevic@scirent.com</email>
      </contact_backup>
      <investigator>
        <last_name>Milovan Petrovic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Serbia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)</keyword>
    <keyword>Renal Compromise</keyword>
    <keyword>Kidney Disease</keyword>
    <keyword>Cardiopulmonary Bypass</keyword>
    <keyword>Renal Assist Device (RAD)</keyword>
    <keyword>Cardiac Surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Renal Insufficiency</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/NCT05990660
  org study id: RAD1117-01
  nct id: NCT05990660
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The study is a prospective, non-randomized early feasibility study intended to evaluate the
        safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist
        Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing
        cardiac surgery.
  The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of
        developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently,
        overall poor outcomes. Patients to be considered for participation include those undergoing
        elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft,
        valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a
        pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion
        criteria will be enrolled into a treatment arm (single-arm study) following the completion of
        informed consent. Participants will receive implantation of the JuxtaFlow Catheters following
        completion of the their cardiac surgery while remaining under anesthesia. Treatment with the
        JuxtaFlow System will be initiated upon the participant's arrival into the intensive care
        unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and
        post-operative data will be collected on participants to include 15- and 30-day follow-up
        periods.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: [Safety] Adverse Events Characterization
  time frame: 30 days
  description: The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.
  measure: [Efficacy] Creatinine Clearance
  time frame: 24 hours
  description: The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.
  measure: [Efficacy] Urine Sodium Excretion
  time frame: 24 hours
  description: The change in urine sodium excretion occurring over the treatment period of 24 hours or less.
  arm group label: Treatment
  arm group type: Experimental
  intervention type: Device
  intervention name: JuxtaFlow System
  description: Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Slobodan Micovic, MD
  role: Principal Investigator
  affiliation: Institute for Cardiovascular Diseases "Dedinje"
  last name: Milovan Petrovic, MD
  role: Principal Investigator
  affiliation: Institute of Cardiovascular Diseases of Vojvodina
  last name: Lance M Black, MD
  phone: (850) 218-5259
  email: lance.black@3ivelabs.com
  last name: Bryan Tucker, PhD
  phone: (919) 942-4511
  email: bryan.tucker@3ivelabs.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Serbia
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Renal Insufficiency
  sharing ipd: No