<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/NCT02210650</url>
  </required_header>
  <id_info>
    <org_study_id>P01 DK 043881 Project 3</org_study_id>
    <nct_id>NCT02210650</nct_id>
  </id_info>
  <brief_title>Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney</brief_title>
  <official_title>Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana Kidney Stone Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA Puget Sound Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana Kidney Stone Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have&#xD;
      small kidney stones that don't cause symptoms. If these small kidney stones are determined to&#xD;
      be asymptomatic (not causing any problems or pain), then most urologists will simply remove&#xD;
      the symptomatic ureteral stone and leave the additional stones in the kidneys. However,&#xD;
      symptomatic kidney stones started as small stones that didn't cause symptoms. This means that&#xD;
      the small stones remaining in the patient's kidney may cause problems later. The purpose of&#xD;
      our research is to test if removing small stones from the kidney prevents future stone&#xD;
      episodes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2022</completion_date>
  <primary_completion_date type="Actual">May 2022</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>Relapse of stone disease on the study side</measure>
    <time_frame>annually up to 5 years after stone removal surgery</time_frame>
    <description>Radiological evidence of significant growth in the size of any pre-existing stone&#xD;
Return for stone removal surgery on the study side&#xD;
Passage of a stone with pain symptoms on the study side resulting in an emergency department visit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Ureteral Stones, Kidney Stones</condition>
  <arm_group>
    <arm_group_label>Symptomatic stone removal</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 1 will receive the standard treatment of having only the symptomatic stone removed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic kidney stones and symptomatic stone removed</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Symptomatic stone removal</intervention_name>
    <description>Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy</description>
    <arm_group_label>Symptomatic stone removal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Asymptomatic kidney stones and ureteral stone removed</intervention_name>
    <description>Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy</description>
    <arm_group_label>Asymptomatic kidney stones and symptomatic stone removed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo surgery (URS or PCNL) for a primary stone.&#xD;
&#xD;
          -  Computed tomography (CT) exam within the 90-day pre-operative period&#xD;
&#xD;
          -  Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in&#xD;
             the contralateral kidney for a primary renal stone or ipsilateral kidney for primary&#xD;
             ureteral stone.&#xD;
&#xD;
          -  Recurrent (having had previous stones) or multiple (simultaneous bilateral stones)&#xD;
             stones&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Age 21 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Age less than 21 years&#xD;
&#xD;
          -  Stones not visible on KUB or CT&#xD;
&#xD;
          -  Patients with systemic disease or renal anatomical disorders (RTA, primary&#xD;
             hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)&#xD;
&#xD;
          -  Any condition (eg, psychiatric illness) or situation that, in the investigator's&#xD;
             opinion, could put the&#xD;
&#xD;
          -  subject at significant risk, confound the study results, or interfere significantly&#xD;
             with the subject's&#xD;
&#xD;
          -  participation in the study.&#xD;
&#xD;
          -  Unwilling to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James E Lingeman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center Department of Urology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195 9472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Administration Puget Sound Heath Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>kidney stone</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>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
    <mesh_term>Calculi</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/NCT02210650
org study id: P01 DK 043881 Project 3
nct id: NCT02210650
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have
      small kidney stones that don't cause symptoms. If these small kidney stones are determined to
      be asymptomatic (not causing any problems or pain), then most urologists will simply remove
      the symptomatic ureteral stone and leave the additional stones in the kidneys. However,
      symptomatic kidney stones started as small stones that didn't cause symptoms. This means that
      the small stones remaining in the patient's kidney may cause problems later. The purpose of
      our research is to test if removing small stones from the kidney prevents future stone
      episodes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relapse of stone disease on the study side
time frame: annually up to 5 years after stone removal surgery
description: Radiological evidence of significant growth in the size of any pre-existing stone
Return for stone removal surgery on the study side
Passage of a stone with pain symptoms on the study side resulting in an emergency department visit
arm group label: Symptomatic stone removal
arm group type: Other
description: Group 1 will receive the standard treatment of having only the symptomatic stone removed
arm group label: Asymptomatic kidney stones and symptomatic stone removed
arm group type: Other
description: Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone
intervention type: Procedure
intervention name: Symptomatic stone removal
description: Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
arm group label: Symptomatic stone removal
intervention type: Procedure
intervention name: Asymptomatic kidney stones and ureteral stone removed
description: Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy
arm group label: Asymptomatic kidney stones and symptomatic stone removed
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: James E Lingeman, MD
role: Principal Investigator
affiliation: Indiana University Health
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis
mesh term: Calculi