<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/NCT02195622</url>
  </required_header>
  <id_info>
    <org_study_id>1305011478R001</org_study_id>
    <nct_id>NCT02195622</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures</brief_title>
  <official_title>Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana Kidney Stone Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Richard Wolf Medical Instruments Corporation (RWMIC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana Kidney Stone Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare efficiency, in terms of tissue morcellation and removal time, of two commercially&#xD;
      available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing&#xD;
      HoLEP procedure for benign prostatic hyperplasia (BPH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical&#xD;
      technique used for treatment of bladder outlet obstruction (BOO) secondary to benign&#xD;
      prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral&#xD;
      resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating&#xD;
      prostates of all sizes and has low perioperative morbidity.&#xD;
&#xD;
      A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect&#xD;
      the obstructing prostate tissue (enucleation). After enucleation is performed, the resected&#xD;
      tissue is advanced into the bladder. The morcellator is then used to cut the tissue into&#xD;
      small pieces which are then removed from the bladder via suction through the morcellator&#xD;
      blades (morcellation). We currently use the first commercially available morcellator&#xD;
      (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope&#xD;
      (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the&#xD;
      procedure.&#xD;
&#xD;
      Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany).&#xD;
      The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis&#xD;
      device&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morcellation Rate</measure>
    <time_frame>Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth</time_frame>
    <description>Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as &quot;morcellation rate.&quot;</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Benign Prostatic Hypertrophy Requiring Surgical Intervention</condition>
  <arm_group>
    <arm_group_label>Lumenis VersaCut Morcellator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wolf Piranha Morcellator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Wolf Piranha Morcellator will be utilized for prostate tissue morcellation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lumenis VersaCut Morcellator</intervention_name>
    <arm_group_label>Lumenis VersaCut Morcellator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wolf Piranha Morcellator</intervention_name>
    <arm_group_label>Wolf Piranha Morcellator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the&#xD;
             prostate.&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Inability to give informed consent.&#xD;
&#xD;
               -  Age less than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IU Health Physicians Urology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>June 20, 2018</results_first_submitted>
  <results_first_submitted_qc>March 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2019</results_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</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>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lumenis VersaCut Morcellator</title>
          <description>Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation&#xD;
Lumenis VersaCut Morcellator</description>
        </group>
        <group group_id="P2">
          <title>Wolf Piranha Morcellator</title>
          <description>Wolf Piranha Morcellator will be utilized for prostate tissue morcellation&#xD;
Wolf Piranha Morcellator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="37"/>
              </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>Lumenis VersaCut Morcellator</title>
          <description>Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation&#xD;
Lumenis VersaCut Morcellator</description>
        </group>
        <group group_id="B2">
          <title>Wolf Piranha Morcellator</title>
          <description>Wolf Piranha Morcellator will be utilized for prostate tissue morcellation&#xD;
Wolf Piranha Morcellator</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="37"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="74"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" lower_limit="45" upper_limit="88"/>
                    <measurement group_id="B2" value="69" lower_limit="50" upper_limit="84"/>
                    <measurement group_id="B3" value="68.5" lower_limit="45" upper_limit="88"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Morcellation Rate</title>
        <description>Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as &quot;morcellation rate.&quot;</description>
        <time_frame>Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumenis VersaCut Morcellator</title>
            <description>Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation&#xD;
Lumenis VersaCut Morcellator</description>
          </group>
          <group group_id="O2">
            <title>Wolf Piranha Morcellator</title>
            <description>Wolf Piranha Morcellator will be utilized for prostate tissue morcellation&#xD;
Wolf Piranha Morcellator</description>
          </group>
        </group_list>
        <measure>
          <title>Morcellation Rate</title>
          <description>Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as &quot;morcellation rate.&quot;</description>
          <units>grams/minute</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="1.3" upper_limit="9.5"/>
                    <measurement group_id="O2" value="5.6" lower_limit="1.4" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse event data collected intraoperatively through hospital discharge, which is typically less than 24 hours total</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wolf Piranha Morcellator</title>
        </group>
        <group group_id="E2">
          <title>Lumenis VersaCut Morcellator</title>
        </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="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>James Lingeman, MD</name_or_title>
      <organization>IU Health Physicians Urology</organization>
      <phone>317-962-3700</phone>
    </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/NCT02195622
org study id: 1305011478R001
nct id: NCT02195622
lead sponsor: 
collaborator: 
has dmc: No
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially
      available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing
      HoLEP procedure for benign prostatic hyperplasia (BPH).
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical
      technique used for treatment of bladder outlet obstruction (BOO) secondary to benign
      prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral
      resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating
      prostates of all sizes and has low perioperative morbidity.

      A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect
      the obstructing prostate tissue (enucleation). After enucleation is performed, the resected
      tissue is advanced into the bladder. The morcellator is then used to cut the tissue into
      small pieces which are then removed from the bladder via suction through the morcellator
      blades (morcellation). We currently use the first commercially available morcellator
      (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope
      (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the
      procedure.

      Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany).
      The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis
      device
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Morcellation Rate
time frame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
description: Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."
arm group label: Lumenis VersaCut Morcellator
arm group type: Other
description: Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation
arm group label: Wolf Piranha Morcellator
arm group type: Other
description: Wolf Piranha Morcellator will be utilized for prostate tissue morcellation
intervention type: Device
intervention name: Lumenis VersaCut Morcellator
arm group label: Lumenis VersaCut Morcellator
intervention type: Device
intervention name: Wolf Piranha Morcellator
arm group label: Wolf Piranha Morcellator
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hypertrophy
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 