<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/NCT03758222</url>
  </required_header>
  <id_info>
    <org_study_id>10-CIP-1164</org_study_id>
    <secondary_id>PN-7585,-7998 10-MSC-1082</secondary_id>
    <nct_id>NCT03758222</nct_id>
  </id_info>
  <brief_title>Safety and Feasibility of the XFLO Expander System (Mercury)</brief_title>
  <acronym>EXPANDER-1</acronym>
  <official_title>A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedeonBio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedeonBio, Inc.</source>
  <oversight_info>
    <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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the safety and feasibility of the Mercury Expander system and procedure to&#xD;
      treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow&#xD;
      obstruction from benign prostatic hyperplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the&#xD;
      safety and feasibility of the Mercury Expander system in patients with lower urinary tract&#xD;
      symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia&#xD;
      (BPH).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from Unanticipated adverse device effects (UADEs)</measure>
    <time_frame>1 month (Arm-1)</time_frame>
    <description>Measure any device or procedure related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from Unanticipated adverse device effects (UADEs)</measure>
    <time_frame>6 months (Arm-2)</time_frame>
    <description>Measure any device or procedure related adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from Unanticipated adverse device effects (UADEs)</measure>
    <time_frame>7 months (Arm-1)</time_frame>
    <description>Measure any device or procedure related adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from Unanticipated adverse device effects (UADEs)</measure>
    <time_frame>12 months (Arm-2)</time_frame>
    <description>Measure any device or procedure related adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Prostate Symptom Score (IPSS)</measure>
    <time_frame>1 month and 7 months (Arm-1)</time_frame>
    <description>Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Prostate Symptom Score (IPSS)</measure>
    <time_frame>6 and 12 months (Arm-2)</time_frame>
    <description>Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Arm-1: Device implantation for 1 month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm-2: Device implantation for 6 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm-3: Device implantation for 12 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XFLO Expander System</intervention_name>
    <description>Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)</description>
    <arm_group_label>Arm-1: Device implantation for 1 month</arm_group_label>
    <arm_group_label>Arm-2: Device implantation for 6 months</arm_group_label>
    <arm_group_label>Arm-3: Device implantation for 12 months</arm_group_label>
    <other_name>Mercury</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male gender&#xD;
&#xD;
          -  Age ≥ 50 years&#xD;
&#xD;
          -  Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound&#xD;
             (TRUS)&#xD;
&#xD;
          -  Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum,&#xD;
             using cystoscopy (or prostate length from bladder neck to external sphincter of&#xD;
             2.0-8.0 cm during screening visit, using ultrasound).&#xD;
&#xD;
          -  Medication history&#xD;
&#xD;
               -  Not on BPH related medication for the past 6 months.&#xD;
&#xD;
               -  If on BPH related medication:&#xD;
&#xD;
                    -  On 5-alpha-reductase inhibitors (ARIs), the patient must be on the&#xD;
                       medication for at least 3 months with a stable voiding pattern&#xD;
&#xD;
                    -  On alpha-blockers, the patient must be on the medication for at least 3&#xD;
                       weeks with a stable voiding pattern&#xD;
&#xD;
          -  Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS):&#xD;
&#xD;
               -  With International Prostate Symptom Score (IPSS) &gt; 13; Qmax &lt; 12 mL/sec on a&#xD;
                  voided volume ≥125 mL; Post-void residual (PVR) &lt; 250 mL; QoL score ≥ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous BPH procedure&#xD;
&#xD;
          -  Median prostatic lobe or high bladder neck&#xD;
&#xD;
          -  Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or&#xD;
             recurrent requiring 2 or more dilatations&#xD;
&#xD;
          -  Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last&#xD;
             6 months, or a positive biopsy showing cancer&#xD;
&#xD;
          -  Cystolithiasis within the prior 3 months&#xD;
&#xD;
          -  History of neurogenic bladder or urinary retention with PVR &gt;1000mL.&#xD;
&#xD;
          -  Serum creatinine &gt;1.8 mg/dl or upper-tract disease which compromises renal function&#xD;
&#xD;
          -  Current or recent Urinary Tract Infection (UTI) or disease&#xD;
&#xD;
          -  Known allergy to nickel&#xD;
&#xD;
          -  Life expectancy of less than 24 months&#xD;
&#xD;
          -  Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin&#xD;
             ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)&#xD;
&#xD;
          -  Anticipated need for additional surgery or treatments for comorbidities during the&#xD;
             study period.&#xD;
&#xD;
          -  Current gross hematuria&#xD;
&#xD;
          -  Other co-morbidities that could impact the study results&#xD;
&#xD;
          -  Unable or unwilling to complete all required questionnaires and follow-up assessments&#xD;
&#xD;
          -  Unable or unwilling to sign informed consent form&#xD;
&#xD;
          -  Currently enrolled in any other investigational clinical research trial that has not&#xD;
             completed the primary endpoint.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Benign prostatic hyperplasia (BPH) is a male disease</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry Woo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Australian Clinical Trials Pty Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Australian Clinical Trials Pty Ltd</name>
      <address>
        <city>Wahroonga</city>
        <state>New South Wales</state>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brunswick Medical Center</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center of Urology</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Georgia</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</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>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/NCT03758222
org study id: 10-CIP-1164
secondary id: PN-7585,-7998 10-MSC-1082
nct id: NCT03758222
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
To demonstrate the safety and feasibility of the Mercury Expander system and procedure to
      treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow
      obstruction from benign prostatic hyperplasia.
A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the
      safety and feasibility of the Mercury Expander system in patients with lower urinary tract
      symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia
      (BPH).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from Unanticipated adverse device effects (UADEs)
time frame: 1 month (Arm-1)
description: Measure any device or procedure related adverse events
measure: Freedom from Unanticipated adverse device effects (UADEs)
time frame: 6 months (Arm-2)
description: Measure any device or procedure related adverse events
measure: Freedom from Unanticipated adverse device effects (UADEs)
time frame: 7 months (Arm-1)
description: Measure any device or procedure related adverse events
measure: Freedom from Unanticipated adverse device effects (UADEs)
time frame: 12 months (Arm-2)
description: Measure any device or procedure related adverse events
measure: Change in International Prostate Symptom Score (IPSS)
time frame: 1 month and 7 months (Arm-1)
description: Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
measure: Change in International Prostate Symptom Score (IPSS)
time frame: 6 and 12 months (Arm-2)
description: Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
arm group label: Arm-1: Device implantation for 1 month
arm group type: Experimental
description: Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.
arm group label: Arm-2: Device implantation for 6 months
arm group type: Experimental
description: Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.
arm group label: Arm-3: Device implantation for 12 months
arm group type: Experimental
description: Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.
intervention type: Device
intervention name: XFLO Expander System
description: Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
arm group label: Arm-1: Device implantation for 1 month
arm group label: Arm-2: Device implantation for 6 months
arm group label: Arm-3: Device implantation for 12 months
other name: Mercury
criteria: 
gender: Male
gender based: Yes
gender description: Benign prostatic hyperplasia (BPH) is a male disease
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Henry Woo, MD
role: Principal Investigator
affiliation: Australian Clinical Trials Pty Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Georgia
country: Taiwan
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia