<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/NCT03040466</url>
  </required_header>
  <id_info>
    <org_study_id>16-20844</org_study_id>
    <nct_id>NCT03040466</nct_id>
  </id_info>
  <brief_title>Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope</brief_title>
  <official_title>Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases&#xD;
      including urinary stones. However, they require a long turnover time between procedures&#xD;
      because of the sterilization process. Moreover, repeated use of a scope ultimately&#xD;
      deteriorates its image quality which leads to a high maintenance cost in the long-term. A&#xD;
      disposable digital flexible ureteroscope was released in the United States in January 2016,&#xD;
      offering an improved image resolution, new scope performance characteristics with every case,&#xD;
      and no need for sterilization and repair. Preliminary data from our center has demonstrated&#xD;
      that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope&#xD;
      and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment&#xD;
      with disposable scopes may be more effective for patients and facilitate cost management&#xD;
      within the hospital.&#xD;
&#xD;
      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes&#xD;
      between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, prospective, randomized controlled pragmatic clinical trial designed&#xD;
      to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in&#xD;
      upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or&#xD;
      ureteral stones are planned to recruit for the study. All subjects will be computer&#xD;
      sequence-randomized into having their ureteroscopic treatment performed with a disposable&#xD;
      (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible&#xD;
      ureteroscope. Patient's demographics, physical, laboratory, and image findings will be&#xD;
      collected before surgery. These clinical data are already being collected as part of an&#xD;
      ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue&#xD;
      and need for a second ureteroscope during the case will be recorded during the treatment&#xD;
      course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The&#xD;
      condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.&#xD;
&#xD;
      Screening data will be reviewed to determine subject eligibility. Subjects who meet all&#xD;
      inclusion criteria and none of the exclusion criteria will be entered into the study.&#xD;
&#xD;
      The following surgical treatment will be used similarly for all three randomized arms and&#xD;
      represents standard of case therapy:&#xD;
&#xD;
      Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy&#xD;
      position. All procedures are performed under direct videoscopic and fluoroscopic guidance.&#xD;
      Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit.&#xD;
      Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access&#xD;
      sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using&#xD;
      a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a&#xD;
      holmium YAG laser. Basket extraction of residual fragments is done until visual complete&#xD;
      clearance of stone fragments is achieved.&#xD;
&#xD;
      After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the&#xD;
      end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.&#xD;
&#xD;
      The total duration of the study is expected to be one year for subject recruitment and one&#xD;
      year and six months for final subject follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <intervention_model_description>Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Procedure Time</measure>
    <time_frame>at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are Stone Free</measure>
    <time_frame>three month after surgery</time_frame>
    <description>this will be determined by either CT, US, or KUB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Complications</measure>
    <time_frame>from during the surgery to three months after the surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Kidney Calculi</condition>
  <condition>Ureter Calculi</condition>
  <arm_group>
    <arm_group_label>reusable fiberoptic ureteroscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>disposable digital ureteroscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>reusable fiberoptic ureteroscope</intervention_name>
    <description>We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
    <arm_group_label>reusable fiberoptic ureteroscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>disposable digital ureteroscope</intervention_name>
    <description>We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
    <arm_group_label>disposable digital ureteroscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years of age at their first clinical visit.&#xD;
&#xD;
          2. Patients with either unilateral or bilateral upper urinary tract stone of any size and&#xD;
             location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound,&#xD;
             computed tomography or plain radiographic imaging&#xD;
&#xD;
          3. Patients being able and willing to provide consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious illness likely to cause death within the next 5 years, so as to exclude&#xD;
             significant metabolic derangements that might lead to adverse surgical outcome.&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
          3. Staged ureteroscopic procedure.&#xD;
&#xD;
          4. Antegrade flexible ureteroscopy.&#xD;
&#xD;
          5. Dual procedures (ureteroscopy concurrently performed with other operations).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Chi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urology, University of California San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Healy KA, Pak RW, Cleary RC, Colon-Herdman A, Bagley DH. Hand problems among endourologists. J Endourol. 2011 Dec;25(12):1915-20. doi: 10.1089/end.2011.0128. Epub 2011 Oct 17.</citation>
    <PMID>22004843</PMID>
  </reference>
  <reference>
    <citation>Karaolides T, Bach C, Kachrilas S, Goyal A, Masood J, Buchholz N. Improving the durability of digital flexible ureteroscopes. Urology. 2013 Apr;81(4):717-22. doi: 10.1016/j.urology.2013.01.016. Epub 2013 Mar 7.</citation>
    <PMID>23465156</PMID>
  </reference>
  <reference>
    <citation>Multescu R, Geavlete B, Geavlete P. A new era: performance and limitations of the latest models of flexible ureteroscopes. Urology. 2013 Dec;82(6):1236-9. doi: 10.1016/j.urology.2013.07.022. Epub 2013 Aug 28.</citation>
    <PMID>23992972</PMID>
  </reference>
  <reference>
    <citation>Somani BK, Al-Qahtani SM, de Medina SD, Traxer O. Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology. 2013 Nov;82(5):1017-9. doi: 10.1016/j.urology.2013.07.017. Epub 2013 Aug 31.</citation>
    <PMID>24001703</PMID>
  </reference>
  <reference>
    <citation>Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.</citation>
    <PMID>24837456</PMID>
  </reference>
  <reference>
    <citation>de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.</citation>
    <PMID>24147820</PMID>
  </reference>
  <reference>
    <citation>Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.</citation>
    <PMID>24890883</PMID>
  </reference>
  <reference>
    <citation>Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.</citation>
    <PMID>25286008</PMID>
  </reference>
  <reference>
    <citation>Buttice S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. doi: 10.5173/ceju.2016.872. Epub 2016 Aug 26. No abstract available.</citation>
    <PMID>27730000</PMID>
  </reference>
  <reference>
    <citation>Doizi S, Kamphuis G, Giusti G, Andreassen KH, Knoll T, Osther PJ, Scoffone C, Perez-Fentes D, Proietti S, Wiseman O, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue): a European prospective multicentric feasibility study. World J Urol. 2017 May;35(5):809-818. doi: 10.1007/s00345-016-1936-x. Epub 2016 Sep 26.</citation>
    <PMID>27671898</PMID>
  </reference>
  <reference>
    <citation>Martin CJ, McAdams SB, Abdul-Muhsin H, Lim VM, Nunez-Nateras R, Tyson MD, Humphreys MR. The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis. J Urol. 2017 Mar;197(3 Pt 1):730-735. doi: 10.1016/j.juro.2016.09.085. Epub 2016 Sep 28.</citation>
    <PMID>27693449</PMID>
  </reference>
  <results_reference>
    <citation>Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T. A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. J Endourol. 2017 May;31(5):468-475. doi: 10.1089/end.2017.0027. Epub 2017 Mar 13.</citation>
    <PMID>28287823</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>January 31, 2020</results_first_submitted>
  <results_first_submitted_qc>September 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2020</results_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ureteroscopy</keyword>
  <keyword>flexible ureteroscope</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Reusable Fiberoptic Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
        <group group_id="P2">
          <title>Disposable Digital Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reusable Fiberoptic Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
        <group group_id="B2">
          <title>Disposable Digital Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="65"/>
            <count group_id="B2" value="115"/>
            <count group_id="B3" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.5" spread="12.6"/>
                    <measurement group_id="B2" value="55.8" spread="15.1"/>
                    <measurement group_id="B3" value="53.8" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Procedure Time</title>
        <time_frame>at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reusable Fiberoptic Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
          <group group_id="O2">
            <title>Disposable Digital Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Procedure Time</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.5" spread="37.0"/>
                    <measurement group_id="O2" value="54.1" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are Stone Free</title>
        <description>this will be determined by either CT, US, or KUB</description>
        <time_frame>three month after surgery</time_frame>
        <population>Postoperative imaging was requested of all patients, but the total study group did not follow up with kidney, ureter, and bladder radiograph or ultrasound surveillance imaging. Participants with post operative imaging included here.</population>
        <group_list>
          <group group_id="O1">
            <title>Reusable Fiberoptic Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
          <group group_id="O2">
            <title>Disposable Digital Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are Stone Free</title>
          <description>this will be determined by either CT, US, or KUB</description>
          <population>Postoperative imaging was requested of all patients, but the total study group did not follow up with kidney, ureter, and bladder radiograph or ultrasound surveillance imaging. Participants with post operative imaging included here.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Complications</title>
        <time_frame>from during the surgery to three months after the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reusable Fiberoptic Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
          <group group_id="O2">
            <title>Disposable Digital Ureteroscope</title>
            <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complications</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Reusable Fiberoptic Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
        <group group_id="E2">
          <title>Disposable Digital Ureteroscope</title>
          <description>For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.&#xD;
disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Presence of postoperative complications</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Thomas Chi</name_or_title>
      <organization>UCSF</organization>
      <phone>415-476-1611</phone>
      <email>tom.chi@ucsf.edu;manint.usawachintachit@ucsf.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03040466
org study id: 16-20844
nct id: NCT03040466
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases
      including urinary stones. However, they require a long turnover time between procedures
      because of the sterilization process. Moreover, repeated use of a scope ultimately
      deteriorates its image quality which leads to a high maintenance cost in the long-term. A
      disposable digital flexible ureteroscope was released in the United States in January 2016,
      offering an improved image resolution, new scope performance characteristics with every case,
      and no need for sterilization and repair. Preliminary data from our center has demonstrated
      that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope
      and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment
      with disposable scopes may be more effective for patients and facilitate cost management
      within the hospital.

      Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes
      between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.
This is a single center, prospective, randomized controlled pragmatic clinical trial designed
      to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in
      upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or
      ureteral stones are planned to recruit for the study. All subjects will be computer
      sequence-randomized into having their ureteroscopic treatment performed with a disposable
      (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible
      ureteroscope. Patient's demographics, physical, laboratory, and image findings will be
      collected before surgery. These clinical data are already being collected as part of an
      ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue
      and need for a second ureteroscope during the case will be recorded during the treatment
      course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The
      condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.

      Screening data will be reviewed to determine subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the study.

      The following surgical treatment will be used similarly for all three randomized arms and
      represents standard of case therapy:

      Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy
      position. All procedures are performed under direct videoscopic and fluoroscopic guidance.
      Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit.
      Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access
      sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using
      a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a
      holmium YAG laser. Basket extraction of residual fragments is done until visual complete
      clearance of stone fragments is achieved.

      After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the
      end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.

      The total duration of the study is expected to be one year for subject recruitment and one
      year and six months for final subject follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Procedure Time
time frame: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes
measure: Number of Participants That Are Stone Free
time frame: three month after surgery
description: this will be determined by either CT, US, or KUB
measure: Number of Participants With Complications
time frame: from during the surgery to three months after the surgery
arm group label: reusable fiberoptic ureteroscope
arm group type: Active Comparator
description: For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
arm group label: disposable digital ureteroscope
arm group type: Experimental
description: For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
intervention type: Device
intervention name: reusable fiberoptic ureteroscope
description: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
arm group label: reusable fiberoptic ureteroscope
intervention type: Device
intervention name: disposable digital ureteroscope
description: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
arm group label: disposable digital ureteroscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thomas Chi, MD
role: Principal Investigator
affiliation: Urology, University of California San Francisco
facility: 
country: United States
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PMID: 22004843
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PMID: 23465156
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PMID: 23992972
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PMID: 24001703
citation: Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.
PMID: 24837456
citation: de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
PMID: 24147820
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PMID: 24890883
citation: Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.
PMID: 25286008
citation: Buttice S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. doi: 10.5173/ceju.2016.872. Epub 2016 Aug 26. No abstract available.
PMID: 27730000
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PMID: 27671898
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PMID: 27693449
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PMID: 28287823
responsible party type: Sponsor
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 