<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/NCT02967523</url>
  </required_header>
  <id_info>
    <org_study_id>26 October 2016</org_study_id>
    <nct_id>NCT02967523</nct_id>
  </id_info>
  <brief_title>Surefire Precision Infusion System Registry</brief_title>
  <official_title>Surefire Precision Infusion System Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Surefire Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SurefireMedical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project involves the collection and analysis of retrospective and prospective data on&#xD;
      patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision&#xD;
      Infusion System was used/will used be to deliver transarterial chemoembolization with&#xD;
      doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in&#xD;
      a real-world setting as well as identify potential areas for future clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to&#xD;
      prolong survival compared to supportive therapy in certain patients with unresectable HCC,&#xD;
      including patients with unilateral portal vein invasion (PVI). The best results for cTACE&#xD;
      occur when the dose is delivered in a highly targeted manner into the tumor. Dense&#xD;
      accumulation of embolic spheres or lipiodol into the tumor as documented by computed&#xD;
      tomography (CT) has been shown to have improved outcomes. However, with standard endhole&#xD;
      catheters, achieving maximum delivery of embolic agents is significantly limited by the&#xD;
      development of stasis, non-target delivery and subsequent non-target injury. Thus, when this&#xD;
      procedure is performed with endhole catheters, there is significant variability in the&#xD;
      delivery of the agent that is entirely dependent on the flow pattern of the target tumor.&#xD;
      Therefore, current techniques result in various degrees of embolization with variability in&#xD;
      dosages and angiographic endpoints.&#xD;
&#xD;
      DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin&#xD;
      exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized&#xD;
      for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are&#xD;
      currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria&#xD;
      for possible liver transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">June 18, 2018</completion_date>
  <primary_completion_date type="Actual">June 18, 2018</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>Other</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Objective tumor response</measure>
    <time_frame>6 months following initial DEB-TACE procedure.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response</measure>
    <time_frame>1 and 3 months following initial DEB-TACE procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)</measure>
    <time_frame>6 months following initial DEB-TACE procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor characteristics</measure>
    <time_frame>DEB-TACE procedure(s)</time_frame>
    <description>Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)</measure>
    <time_frame>DEB-TACE procedure(s)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alpha-fetoprotein (AFP) blood levels</measure>
    <time_frame>1, 3 and 6 months following initial DEB-TACE procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">111</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DEB-TACE with Surefire Precision Infusion System</intervention_name>
    <description>Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been diagnosed with HCC in which the Surefire Precision Infusion System&#xD;
        was used/will be used to deliver DEB-TACE.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone or will undergo DEB-TACE for HCC delivered by the&#xD;
             Surefire® Precision Infusion System&#xD;
&#xD;
          -  Patients aged 18 years or older&#xD;
&#xD;
          -  Diagnosis of HCC&#xD;
&#xD;
          -  Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥&#xD;
             1.5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for doxorubicin administration&#xD;
&#xD;
          -  Vessels providing flow to the tumor that are &lt; 1.5 mm in diameter(s)&#xD;
&#xD;
          -  Patients who are unable to provide informed consent&#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>Baljendra Kapoor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>September 10, 2018</last_update_submitted>
  <last_update_submitted_qc>September 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>DEB-TACE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02967523
org study id: 26 October 2016
nct id: NCT02967523
lead sponsor: 
has dmc: No
This project involves the collection and analysis of retrospective and prospective data on
      patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision
      Infusion System was used/will used be to deliver transarterial chemoembolization with
      doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in
      a real-world setting as well as identify potential areas for future clinical research.
Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to
      prolong survival compared to supportive therapy in certain patients with unresectable HCC,
      including patients with unilateral portal vein invasion (PVI). The best results for cTACE
      occur when the dose is delivered in a highly targeted manner into the tumor. Dense
      accumulation of embolic spheres or lipiodol into the tumor as documented by computed
      tomography (CT) has been shown to have improved outcomes. However, with standard endhole
      catheters, achieving maximum delivery of embolic agents is significantly limited by the
      development of stasis, non-target delivery and subsequent non-target injury. Thus, when this
      procedure is performed with endhole catheters, there is significant variability in the
      delivery of the agent that is entirely dependent on the flow pattern of the target tumor.
      Therefore, current techniques result in various degrees of embolization with variability in
      dosages and angiographic endpoints.

      DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin
      exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized
      for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are
      currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria
      for possible liver transplantation.
observational model: Case-Only
time perspective: Other
measure: Objective tumor response
time frame: 6 months following initial DEB-TACE procedure.
measure: Objective tumor response
time frame: 1 and 3 months following initial DEB-TACE procedure
measure: Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
time frame: 6 months following initial DEB-TACE procedure
measure: Tumor characteristics
time frame: DEB-TACE procedure(s)
description: Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)
measure: Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)
time frame: DEB-TACE procedure(s)
measure: Changes in alpha-fetoprotein (AFP) blood levels
time frame: 1, 3 and 6 months following initial DEB-TACE procedure
intervention type: Device
intervention name: DEB-TACE with Surefire Precision Infusion System
description: Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Baljendra Kapoor, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
sharing ipd: No