<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/NCT03794102</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00005780</org_study_id>
    <nct_id>NCT03794102</nct_id>
  </id_info>
  <brief_title>Water Versus Saline as Irrigation Fluid for Ureteroscopy</brief_title>
  <official_title>The Effects of Water Versus Saline on Absorption Rates and Visualization During Ureteroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to determine the rate of absorption of fluids (water or saline)&#xD;
      during ureteroscopy and to assess the effects on electrolyte levels. The investigators also&#xD;
      want to measure how much better the urologist can see the ureter based on the type of&#xD;
      irrigation fluid that is used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of fluid irrigation is important during urologic procedures. There is little research&#xD;
      done on the use of water versus saline for irrigation during ureteroscopy.&#xD;
&#xD;
      This study will evaluate whether the use of water or saline during ureteroscopy has any&#xD;
      clinical implications. The investigators will compare the amount of fluid absorbed and&#xD;
      differences in electrolytes between the two participant groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 22, 2017</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>Other</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of irrigation fluid used during ureteroscopy</measure>
    <time_frame>Measurement will be performed day of ureteroscopy</time_frame>
    <description>At conclusion of the ureteroscopy, the bag with the remaining fluid will be weighed to determine amount of fluid used. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum sodium levels</measure>
    <time_frame>Measurement will be performed day of ureteroscopy</time_frame>
    <description>Blood samples will be drawn preoperatively and at conclusion of case (prior to awakening the participant) to assess the serum sodium levels (mEq/L). The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgeon's rating of ureteroscopic visualization</measure>
    <time_frame>Measurement will be performed day of ureteroscopy</time_frame>
    <description>The surgeon will be asked to rate the degree of ureteroscopic visualization on a scale of 1-5, where 1=Poor visualization and 5= Excellent visualization. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of fluid clarity</measure>
    <time_frame>Measurement will be performed day of ureteroscopy</time_frame>
    <description>Fluid clarity was assessed by taking turbidity (cloudiness) measurements of renal fluid (in nephelometric turbidity units (NTU)) with a turbidimeter. The average of three measurements of turbidity was used at the fluid clarity measurement of each case, to supplement the ureteroscopic visualization measurement by surgeon rating. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Ureteral Stricture</condition>
  <condition>Hydronephrosis</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Ureteroscopy with water irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Water will be used as the irrigation fluid during the ureteroscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ureteroscopy with saline irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Saline will be used as the irrigation fluid during the ureteroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Sterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.</description>
    <arm_group_label>Ureteroscopy with water irrigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.</description>
    <arm_group_label>Ureteroscopy with saline irrigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
          -  Participants meeting medical requirements to undergo ureteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Kenneth Ogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Kenneth Ogan, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Hydronephrosis</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/NCT03794102
org study id: IRB00005780
nct id: NCT03794102
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the rate of absorption of fluids (water or saline)
      during ureteroscopy and to assess the effects on electrolyte levels. The investigators also
      want to measure how much better the urologist can see the ureter based on the type of
      irrigation fluid that is used.
The use of fluid irrigation is important during urologic procedures. There is little research
      done on the use of water versus saline for irrigation during ureteroscopy.

      This study will evaluate whether the use of water or saline during ureteroscopy has any
      clinical implications. The investigators will compare the amount of fluid absorbed and
      differences in electrolytes between the two participant groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: Amount of irrigation fluid used during ureteroscopy
time frame: Measurement will be performed day of ureteroscopy
description: At conclusion of the ureteroscopy, the bag with the remaining fluid will be weighed to determine amount of fluid used. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
measure: Change in serum sodium levels
time frame: Measurement will be performed day of ureteroscopy
description: Blood samples will be drawn preoperatively and at conclusion of case (prior to awakening the participant) to assess the serum sodium levels (mEq/L). The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
measure: Surgeon's rating of ureteroscopic visualization
time frame: Measurement will be performed day of ureteroscopy
description: The surgeon will be asked to rate the degree of ureteroscopic visualization on a scale of 1-5, where 1=Poor visualization and 5= Excellent visualization. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
measure: Measurement of fluid clarity
time frame: Measurement will be performed day of ureteroscopy
description: Fluid clarity was assessed by taking turbidity (cloudiness) measurements of renal fluid (in nephelometric turbidity units (NTU)) with a turbidimeter. The average of three measurements of turbidity was used at the fluid clarity measurement of each case, to supplement the ureteroscopic visualization measurement by surgeon rating. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.
arm group label: Ureteroscopy with water irrigation
arm group type: Active Comparator
description: Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Water will be used as the irrigation fluid during the ureteroscopy.
arm group label: Ureteroscopy with saline irrigation
arm group type: Active Comparator
description: Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Saline will be used as the irrigation fluid during the ureteroscopy.
intervention type: Other
intervention name: Water
description: Sterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
arm group label: Ureteroscopy with water irrigation
intervention type: Other
intervention name: Saline
description: 0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
arm group label: Ureteroscopy with saline irrigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Ogan, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Kenneth Ogan, MD
investigator title: Professor
mesh term: Urolithiasis
mesh term: Hydronephrosis