<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/NCT03043612</url>
  </required_header>
  <id_info>
    <org_study_id>13-15</org_study_id>
    <nct_id>NCT03043612</nct_id>
  </id_info>
  <brief_title>Ureteral Stent Study</brief_title>
  <official_title>Cook Ureteral Stent Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cook Group Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cook Group Incorporated</source>
  <oversight_info>
    <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 study is to evaluate the feasibility of the Cook Ureteral Stent to reduce&#xD;
      post-stent placement pain and urinary symptoms in patients following ureteroscopy for&#xD;
      urolithiasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2015</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-reported body pain score</measure>
    <time_frame>7-days post stent placement</time_frame>
    <description>Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Ureteral Study Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ureteral Control Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin</intervention_name>
    <description>Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis</description>
    <arm_group_label>Ureteral Study Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cook Sof-Flex® Double Pigtail Ureteral Stent</intervention_name>
    <description>Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis</description>
    <arm_group_label>Ureteral Control Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is undergoing ureteroscopy for urolithiasis in which temporary ureteral&#xD;
             stenting is indicated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unwilling or unable to sign and date the informed consent&#xD;
&#xD;
          -  Patient is unwilling to comply with the follow-up study schedule&#xD;
&#xD;
          -  Patient is pregnant, breast-feeding, or planning to become pregnant during the course&#xD;
             of the study&#xD;
&#xD;
          -  Patient is currently taking anti-cholinergic or other anti-spasm medications&#xD;
&#xD;
          -  Patient is currently taking sildenafil, tadalafil, or vardenafil&#xD;
&#xD;
          -  Patient has a known sensitivity to alpha-blocker medications&#xD;
&#xD;
          -  Patient is currently undergoing chemotherapy or radiation therapy&#xD;
&#xD;
          -  Patient has an active urinary tract infection&#xD;
&#xD;
          -  Patient is in chronic renal failure, on hemodialysis, or on chronic peritoneal&#xD;
             dialysis&#xD;
&#xD;
          -  Patient requires bilateral shock wave lithotripsy, bilateral stents, or has bilateral&#xD;
             symptomatic kidney stones&#xD;
&#xD;
          -  Patient has had a ureteral stent within the past three months in either ureter&#xD;
&#xD;
          -  Patient is unable to accurately detect or report bladder function or pain&#xD;
&#xD;
          -  Patient has chronic pain&#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>Chi-Fai Ng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Wales Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales/Chinese University of Hong Kong</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ureteroscopy for urolithiasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxazosin</mesh_term>
  </intervention_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/NCT03043612
org study id: 13-15
nct id: NCT03043612
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility of the Cook Ureteral Stent to reduce
      post-stent placement pain and urinary symptoms in patients following ureteroscopy for
      urolithiasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Patient-reported body pain score
time frame: 7-days post stent placement
description: Comparing the patient-reported body pain score from the USSQ 1 survey between the two study arms
arm group label: Ureteral Study Stent
arm group type: Experimental
description: Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent that is coextruded with an alpha-blocker medication
arm group label: Ureteral Control Stent
arm group type: Active Comparator
description: Commercially available Cook Sof-Flex® Double Pigtail Ureteral Stent
intervention type: Device
intervention name: Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin
description: Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
arm group label: Ureteral Study Stent
intervention type: Device
intervention name: Cook Sof-Flex® Double Pigtail Ureteral Stent
description: Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
arm group label: Ureteral Control Stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chi-Fai Ng
role: Principal Investigator
affiliation: Prince of Wales Hospital
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Urolithiasis
mesh term: Urinary Calculi
mesh term: Doxazosin
sharing ipd: No