<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/NCT03014726</url>
  </required_header>
  <id_info>
    <org_study_id>DSC016</org_study_id>
    <nct_id>NCT03014726</nct_id>
  </id_info>
  <brief_title>ROBUST I Pilot Study</brief_title>
  <acronym>ROBUST</acronym>
  <official_title>ROBUST I Pilot Study, ROBUST I Study, 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to determine the safety and effectiveness for drug coated balloon&#xD;
      (DCB).&#xD;
&#xD;
      Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5&#xD;
      clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs.&#xD;
      women and the etiology of those strictures being different, the study will focus on male&#xD;
      subjects with single anterior urethral stricture. Subjects will be followed up post-treatment&#xD;
      to one year and then annually for up to 5 years. The annual follow up after the first year is&#xD;
      optional.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Actual">October 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Treatment Related Serious Complication</measure>
    <time_frame>90 days post-procedure</time_frame>
    <description>Device related formation of fistula; Device related de novo severe urinary retention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stricture Recurrence Rate</measure>
    <time_frame>90 days post-procedure</time_frame>
    <description>Improvement in IPSS (International Prostate Symptoms Score)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stricture Urethra</condition>
  <arm_group>
    <arm_group_label>DCB Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stricture patients treated by DCB</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urotronic Drug Coated Balloon (DCB)</intervention_name>
    <description>Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.</description>
    <arm_group_label>DCB 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 or bladder neck contracture, less than or&#xD;
             equal to 2.0 cm&#xD;
&#xD;
          4. One to three (1-3) prior diagnosis and treatment of the same stricture (including&#xD;
             self-catheterization) including DVIU (Direct Vision 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.&#xD;
&#xD;
          6. IPSS 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;10 ml/sec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Strictures greater than 2.0 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 and are unable to complete study required&#xD;
             testing, such as uroflowmetry&#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. Presence of local adverse factors, including abnormal prostate making catheterization&#xD;
             difficult, urethral false passage or fistula.&#xD;
&#xD;
          9. Presence of signs of obstructive voiding symptoms not directly attributable to the&#xD;
             stricture such as BPH at the discretion of the clinical investigator&#xD;
&#xD;
         10. Previous radical prostatectomy&#xD;
&#xD;
         11. Previous pelvic radiation&#xD;
&#xD;
         12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the&#xD;
             past 6 months.&#xD;
&#xD;
         13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum&#xD;
             creatinine level greater than 2 mg/dL&#xD;
&#xD;
         14. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication,&#xD;
             anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures),&#xD;
             and antispasmodics where the dose is not stable. (Stable dose is defined as having the&#xD;
             same medication and dose in the last six months.)&#xD;
&#xD;
         15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months&#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>Ian Schorn</last_name>
    <role>Study Director</role>
    <affiliation>Urotronic (Study Sponsor)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Libra Medical Inc</name>
      <address>
        <city>Brooklyn Park</city>
        <state>Minnesota</state>
        <zip>55428</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>reduced urine flow rate</keyword>
  <keyword>low peak flow rate</keyword>
  <keyword>urinary tract infections</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>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/NCT03014726
org study id: DSC016
nct id: NCT03014726
lead sponsor: 
has dmc: No
Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.
The study is designed to determine the safety and effectiveness for drug coated balloon
      (DCB).

      Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5
      clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs.
      women and the etiology of those strictures being different, the study will focus on male
      subjects with single anterior urethral stricture. Subjects will be followed up post-treatment
      to one year and then annually for up to 5 years. The annual follow up after the first year is
      optional.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Treatment Related Serious Complication
time frame: 90 days post-procedure
description: Device related formation of fistula; Device related de novo severe urinary retention
measure: Stricture Recurrence Rate
time frame: 90 days post-procedure
description: Improvement in IPSS (International Prostate Symptoms Score)
arm group label: DCB Treatment
arm group type: Experimental
description: Stricture patients treated by DCB
intervention type: Device
intervention name: Urotronic Drug Coated Balloon (DCB)
description: Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.
arm group label: DCB Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ian Schorn
role: Study Director
affiliation: Urotronic (Study Sponsor)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urethral Stricture
mesh term: Constriction, Pathologic
sharing ipd: No