<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/NCT03270384</url>
  </required_header>
  <id_info>
    <org_study_id>PR1032</org_study_id>
    <nct_id>NCT03270384</nct_id>
  </id_info>
  <brief_title>Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease</brief_title>
  <acronym>ROBUST-II</acronym>
  <official_title>Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Urotronic Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Urotronic Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 described below is designed to assess the safety and device performance for the&#xD;
      drug coated balloon (DCB) for the treatment of urethral stricture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety- Rate of Device Related Serious Complications</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety- Change in IIEF (International Index of Erectile Function)</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy- Stricture Recurrence Rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Urethral Stricture</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urotronic Drug Coated Balloon (DCB)</intervention_name>
    <description>The Urotronic Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male subjects ≥ 18 years' old&#xD;
&#xD;
          2. Visual confirmation of stricture via cystoscopy or urethrogram&#xD;
&#xD;
          3. Single lesion anterior urethral stricture less than or equal to 3 cm&#xD;
&#xD;
          4. Two (2) or more prior diagnosis and treatment of stricture treatments (including&#xD;
             self-catheterization) including DVIU (direct visual internal urethrotomy), but no&#xD;
             prior urethroplasty&#xD;
&#xD;
          5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency,&#xD;
             hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract&#xD;
             infections).&#xD;
&#xD;
          6. IPSS (International Prostate Symptom Score) score of 13 or higher&#xD;
&#xD;
          7. Lumen diameter &lt;12F by urethrogram&#xD;
&#xD;
          8. Able to complete validated questionnaire independently&#xD;
&#xD;
          9. Qmax &lt;12 ml/sec&#xD;
&#xD;
         10. Guidewire must be able to cross the lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Strictures greater than 3.0 cm long.&#xD;
&#xD;
          2. Subjects that have more than 1 stricture.&#xD;
&#xD;
          3. Sensitivity to paclitaxel or on medication that may have negative interaction with&#xD;
             paclitaxel&#xD;
&#xD;
          4. Subjects who have a suprapubic catheter&#xD;
&#xD;
          5. Previous urethroplasty within the anterior urethra&#xD;
&#xD;
          6. Stricture due to bacterial urethritis or untreated gonorrhea&#xD;
&#xD;
          7. Stricture dilated or incised within the last 3 months&#xD;
&#xD;
          8. History of over active bladder or stress incontinence&#xD;
&#xD;
          9. Previous radical prostatectomy&#xD;
&#xD;
         10. Previous pelvic radiation&#xD;
&#xD;
         11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the&#xD;
             past 6 months.&#xD;
&#xD;
         12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra&#xD;
             or prostate&#xD;
&#xD;
         13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sean Elliott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology</name>
      <address>
        <city>Hanover</city>
        <state>Maryland</state>
        <zip>21076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Urology</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early feasibility</keyword>
  <keyword>non-randomized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urethral Stricture</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03270384
org study id: PR1032
nct id: NCT03270384
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The study described below is designed to assess the safety and device performance for the
      drug coated balloon (DCB) for the treatment of urethral stricture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Safety- Rate of Device Related Serious Complications
time frame: 90 days
measure: Safety- Change in IIEF (International Index of Erectile Function)
time frame: 90 days
measure: Efficacy- Stricture Recurrence Rate
time frame: 6 months
arm group label: Treatment
arm group type: Experimental
description: Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)
intervention type: Device
intervention name: Urotronic Drug Coated Balloon (DCB)
description: The Urotronic Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
arm group label: Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sean Elliott, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urethral Stricture
mesh term: Constriction, Pathologic
sharing ipd: Undecided