<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/NCT03795545</url>
  </required_header>
  <id_info>
    <org_study_id>16231</org_study_id>
    <nct_id>NCT03795545</nct_id>
  </id_info>
  <brief_title>Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value</brief_title>
  <acronym>ESWL</acronym>
  <official_title>Ultraslow Full-power SWL Versus Slow SWL in Stones With High Attenuation Value</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high&#xD;
      attenuation value&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">August 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 16, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stone free rate</measure>
    <time_frame>3 months following last session of SWL</time_frame>
    <description>Complete clearance of stones in addition to clinically insignificant residual fragments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications rate</measure>
    <time_frame>3 months following last session of SWL</time_frame>
    <description>Comparison of rate of complications in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Ureteric Stone</condition>
  <arm_group>
    <arm_group_label>Ultraslow shock wave lithotripsy (SWL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.&#xD;
The rest of the session at 22kv (full power).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slow power-ramping SWL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SWL</intervention_name>
    <description>Shock wave lithotripsy</description>
    <arm_group_label>Slow power-ramping SWL</arm_group_label>
    <arm_group_label>Ultraslow shock wave lithotripsy (SWL)</arm_group_label>
    <other_name>ESWL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single upper ureteric stone less than or equal to 2 cm&#xD;
&#xD;
          -  radio-opaque stone&#xD;
&#xD;
          -  high attenuation value (≥ 1000 HU) stone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal renal anatomy&#xD;
&#xD;
          -  renal insufficiency&#xD;
&#xD;
          -  solitary kidney&#xD;
&#xD;
          -  coagulopathies&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  renal artery or aortic aneurysm&#xD;
&#xD;
          -  active urinary tract infection&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe skeletal malformations (spinal deformity) precluding proper stone localization&#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>Ahmad Aref Al-Dessoukey, Ass. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Beni-Suef University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beni-Suef Hospitals</name>
      <address>
        <city>Banī Suwayf</city>
        <state>Outside U.S./Canada</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>December 7, 2019</last_update_submitted>
  <last_update_submitted_qc>December 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Said ElSheemy</investigator_full_name>
    <investigator_title>Associate Professor of Urology</investigator_title>
  </responsible_party>
  <keyword>ureteric stone</keyword>
  <keyword>SWL</keyword>
  <keyword>High density stones</keyword>
  <keyword>Ultraslow SWL</keyword>
  <keyword>Slow SWL</keyword>
  <keyword>Ramping</keyword>
  <keyword>Pause</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_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/NCT03795545
org study id: 16231
nct id: NCT03795545
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high
      attenuation value
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: stone free rate
time frame: 3 months following last session of SWL
description: Complete clearance of stones in addition to clinically insignificant residual fragments
measure: Complications rate
time frame: 3 months following last session of SWL
description: Comparison of rate of complications in both groups
arm group label: Ultraslow shock wave lithotripsy (SWL)
arm group type: Active Comparator
description: SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.
The rest of the session at 22kv (full power).
arm group label: Slow power-ramping SWL
arm group type: Active Comparator
description: SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.
intervention type: Procedure
intervention name: SWL
description: Shock wave lithotripsy
arm group label: Slow power-ramping SWL
arm group label: Ultraslow shock wave lithotripsy (SWL)
other name: ESWL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmad Aref Al-Dessoukey, Ass. Prof.
role: Study Director
affiliation: Beni-Suef University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Said ElSheemy
investigator title: Associate Professor of Urology
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis
mesh term: Calculi
sharing ipd: No