<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/NCT02252549</url>
  </required_header>
  <id_info>
    <org_study_id>NL50451.018.14</org_study_id>
    <nct_id>NCT02252549</nct_id>
  </id_info>
  <brief_title>An International Randomized Study to Compare SPIES Versus WLI</brief_title>
  <official_title>The SPIES Non-Muscle-Invasive Bladder Cancer Study - A Multicenter Randomized Controlled Study; A Multicenter International Randomized Controlled Study to Compare the Outcome Using the Storz Professional Image Enhancement System (SPIES) Versus White Light Imaging (WLI) During TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Research Office of the Endourological Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Research Office of the Endourological Society</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multicenter randomized controlled trial in which the efficacy between SPIES&#xD;
      assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will&#xD;
      undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive&#xD;
      treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as&#xD;
      short and long-term follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter randomized controlled trial in which the recurrence rates of&#xD;
      cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified&#xD;
      by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and&#xD;
      macroscopic findings (papillary or flat, where CIS is scored as flat lesion). Patients&#xD;
      randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB,&#xD;
      whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB. WLI is&#xD;
      chosen as control, since it is considered the gold standard for detecting bladder tumors.&#xD;
      Short and long term follow up will be recorded in order to evaluate the health gains for&#xD;
      patients over a longer period. Perioperative (30 days) complications will be compared between&#xD;
      the two treatment arms to evaluate the safety of SPIES.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">July 2021</completion_date>
  <primary_completion_date type="Actual">April 2020</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SPIES+WLI assisted TURB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>WLI assisted TURB</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPIES+WLI assisted TURB</intervention_name>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WLI assisted TURB</intervention_name>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has signed informed consent&#xD;
&#xD;
          -  Is scheduled for treatment of a primary or recurrent NMIBC&#xD;
&#xD;
          -  Is aged 18 years or older&#xD;
&#xD;
          -  Has or has had no tumors in the upper urinary tract&#xD;
&#xD;
          -  Has had no previous irradiation of the pelvis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked&#xD;
             amounts of blood in the urine which may interfere with cystoscopy)&#xD;
&#xD;
          -  Participation in other clinical studies with investigational drugs either concurrently&#xD;
             or within the last 30 days&#xD;
&#xD;
          -  Pregnancy or breast-feeding (all women of child-bearing potential must document a&#xD;
             negative serum or urine pregnancy test at screening and are suggested to use the&#xD;
             contraceptive pill or an intrauterine device (IUD) during the treatments and for at&#xD;
             least one months thereafter)&#xD;
&#xD;
          -  Conditions associated with a risk of poor protocol compliance&#xD;
&#xD;
          -  Has had instillation therapy in the six months prior to the screening visit&#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>Jean de la Rosette</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical Research Office of the Endourological Society</affiliation>
  </overall_official>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</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>Urinary Bladder Neoplasms</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/NCT02252549
org study id: NL50451.018.14
nct id: NCT02252549
lead sponsor: 
has dmc: Yes
This study is a multicenter randomized controlled trial in which the efficacy between SPIES
      assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will
      undergo SPIES assisted TURB, whereas subjects in the control arm (Arm B) will receive
      treatment with WLI assisted TURB only. Baseline characteristics will be recorded, as well as
      short and long-term follow up.
This study is a multicenter randomized controlled trial in which the recurrence rates of
      cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified
      by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and
      macroscopic findings (papillary or flat, where CIS is scored as flat lesion). Patients
      randomized into the experimental arm (Arm A) will undergo SPIES and WLI assisted TURB,
      whereas the patients in the control arm (Arm B) will undergo WLI only assisted TURB. WLI is
      chosen as control, since it is considered the gold standard for detecting bladder tumors.
      Short and long term follow up will be recorded in order to evaluate the health gains for
      patients over a longer period. Perioperative (30 days) complications will be compared between
      the two treatment arms to evaluate the safety of SPIES.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: To compare the recurrence rate of tumor at 12 months following SPIES assisted TURB (Arm A) with White Light Imaging only assisted TURB (Arm B)
time frame: 1 year
measure: 1. To assess the recurrence rate of tumor at short and long term follow up (3 months and 3 years) after SPIES or WLI assisted TURB in patients with NMIBC.
time frame: 3 years
measure: 2. To assess the peri-operative morbidity (30 days) between SPIES and WLI assisted TURB by comparing the proportion of adverse events and using the Clavien-Dindo score.
time frame: 3 years
arm group label: A
arm group type: Active Comparator
description: SPIES+WLI assisted TURB
arm group label: B
arm group type: Active Comparator
description: WLI assisted TURB
intervention type: Device
intervention name: SPIES+WLI assisted TURB
arm group label: A
intervention type: Device
intervention name: WLI assisted TURB
arm group label: B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean de la Rosette
role: Study Chair
affiliation: Clinical Research Office of the Endourological Society
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms