<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/NCT02206243</url>
  </required_header>
  <id_info>
    <org_study_id>3952-12/13</org_study_id>
    <nct_id>NCT02206243</nct_id>
  </id_info>
  <brief_title>Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia</brief_title>
  <acronym>EmboProstate</acronym>
  <official_title>An Observational Study to Evaluate the Safety and Efficacy of Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jena University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jena University Hospital</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>
      The purpose of this observational study is to evaluate the prostatic arterial embolization&#xD;
      (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the&#xD;
      treatment of symptomatic benign prostatic hyperplasia (BPH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EmboProstate is an observational study that collects data of patients with benign prostatic&#xD;
      hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The&#xD;
      study evaluates the efficacy and safety of the microspheres for prostatic arterial&#xD;
      embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be&#xD;
      enrolled in this study. If eligible patients are recruited, they will undergo the prostate&#xD;
      artery embolization procedure in our radiology department. Once the catheter is placed in the&#xD;
      prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected&#xD;
      through the catheter into these small arteries which nourish the prostate. The injected&#xD;
      embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused&#xD;
      by BPH. Within one week after PAE as well as after one, three and six months post-procedure&#xD;
      an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Symptomatic improvement of BPH symptoms (= International Prostate Symptom Score (IPSS) &lt; 18 and reduction &gt; 25% QoL (Quality of Life) &lt; 4 &amp; reduction ≥ &amp; / or Qmax &gt; 15 ml/s &amp; increase of Qmax ≥ 3,0ml/s) at 6 and 12 months post intervention</measure>
    <time_frame>Baseline, follow-up after 1 months, 6 months, 12 months, 24 months</time_frame>
    <description>Improvement of feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)</measure>
    <time_frame>Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months</time_frame>
    <description>The number and the severity of adverse events will be recorded to evaluate the safety of prostate artery embolization. Events will be reported by subjects within the 1st week after PAE and at follow-up after 6 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Qmax (reduction of postvoid residual volume)</measure>
    <time_frame>Follow-up after 6 months</time_frame>
    <description>Measure of urine flow rate. Q max = max flow rate</description>
  </other_outcome>
  <other_outcome>
    <measure>Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound)</measure>
    <time_frame>Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE</time_frame>
    <description>Measuring the percentage of prostate tissue devascularized, based on contrast-enhanced MRI by estimating the prostate volume and the estimated portion that is non-perfused on MRI.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Embozene</arm_group_label>
    <description>Patients receiving Embozene microspheres</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Embozene Microspheres</intervention_name>
    <description>Intraarterial application</description>
    <arm_group_label>Embozene</arm_group_label>
    <other_name>Vascular embolization</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic (within clinical routine)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  adults &gt; 40 years old&#xD;
&#xD;
          -  severe symptomatic BPH with IPSS &gt; 18 and/or QoL &gt; 3 or maximum urinary flow rate&#xD;
             (Qmax) ≤ 15 ml/sec or transurethral catheter for retention&#xD;
&#xD;
          -  no improvement after or intolerance of medical treatment for at least six months&#xD;
&#xD;
          -  prostatic volume &gt; 30 cm³&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  less than 40 years old&#xD;
&#xD;
          -  eGFR &lt; 45 ml/min * m²&#xD;
&#xD;
          -  suspicion of prostatic malignancy&#xD;
&#xD;
          -  prostatic malignancy&#xD;
&#xD;
          -  acute prostatitis or cystitis&#xD;
&#xD;
          -  hydronephrosis&#xD;
&#xD;
          -  bladder stone or bladder diverticulum&#xD;
&#xD;
          -  urethral stenosis&#xD;
&#xD;
          -  major surgery within 4 weeks prior to the screening visit&#xD;
&#xD;
          -  active clinically serious infection&#xD;
&#xD;
          -  progressive arteriosclerosis&#xD;
&#xD;
          -  contraindications against angiography&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Teichgräber, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Diagnostic and Interventional Radiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc-Oliver Grimm, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Urology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tobias Franiel, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Diagnostic and Interventional Radiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Radiology, University Hospital Jena</name>
      <address>
        <city>Jena</city>
        <state>Thuringia</state>
        <zip>07740</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign prostatic hyperplasia</keyword>
  <keyword>BPH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02206243
org study id: 3952-12/13
nct id: NCT02206243
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to evaluate the prostatic arterial embolization
      (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the
      treatment of symptomatic benign prostatic hyperplasia (BPH).
EmboProstate is an observational study that collects data of patients with benign prostatic
      hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The
      study evaluates the efficacy and safety of the microspheres for prostatic arterial
      embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be
      enrolled in this study. If eligible patients are recruited, they will undergo the prostate
      artery embolization procedure in our radiology department. Once the catheter is placed in the
      prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected
      through the catheter into these small arteries which nourish the prostate. The injected
      embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused
      by BPH. Within one week after PAE as well as after one, three and six months post-procedure
      an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.
observational model: Case-Only
time perspective: Prospective
measure: Symptomatic improvement of BPH symptoms (= International Prostate Symptom Score (IPSS) < 18 and reduction > 25% QoL (Quality of Life) < 4 & reduction ≥ & / or Qmax > 15 ml/s & increase of Qmax ≥ 3,0ml/s) at 6 and 12 months post intervention
time frame: Baseline, follow-up after 1 months, 6 months, 12 months, 24 months
description: Improvement of feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia
measure: Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)
time frame: Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months
description: The number and the severity of adverse events will be recorded to evaluate the safety of prostate artery embolization. Events will be reported by subjects within the 1st week after PAE and at follow-up after 6 months.
measure: Change in Qmax (reduction of postvoid residual volume)
time frame: Follow-up after 6 months
description: Measure of urine flow rate. Q max = max flow rate
measure: Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound)
time frame: Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE
description: Measuring the percentage of prostate tissue devascularized, based on contrast-enhanced MRI by estimating the prostate volume and the estimated portion that is non-perfused on MRI.
arm group label: Embozene
description: Patients receiving Embozene microspheres
intervention type: Drug
intervention name: Embozene Microspheres
description: Intraarterial application
arm group label: Embozene
other name: Vascular embolization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ulf Teichgräber, Prof.
role: Study Director
affiliation: Institute of Diagnostic and Interventional Radiology
last name: Marc-Oliver Grimm, Prof.
role: Study Chair
affiliation: Department of Urology
last name: Tobias Franiel, Dr. med.
role: Principal Investigator
affiliation: Institute of Diagnostic and Interventional Radiology
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia