xml: <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/NCT05993546</url>
    </required_header>
    <id_info>
      <org_study_id>23-104</org_study_id>
      <nct_id>NCT05993546</nct_id>
    </id_info>
    <brief_title>Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis</brief_title>
    <official_title>Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to compare two variations of the mini-PCNL procedure using&#xD;
        either a vacuum-assisted sheath or standard sheath which are both used for the surgical&#xD;
        treatment of kidney stones. Both procedure types are commonly used in the treatment of&#xD;
        kidneys stones and they have been shown to be safe and effective in the treatment of stones&#xD;
        similar in size and location to your own.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study we aim to compare two variations of the miniaturized percutaneous&#xD;
        nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of&#xD;
        kidney stones. This procedure involves accessing the kidney via a small temporary tract that&#xD;
        is placed through the patient's back during surgery. Both procedure types are commonly used&#xD;
        in the treatment of kidneys stones and they have been shown to be safe and effective in the&#xD;
        treatment of stones similar in size and location to your own.&#xD;
  &#xD;
        Two procedure types will be investigated:&#xD;
  &#xD;
          1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter)&#xD;
             vacuum-assisted tube with suction capability to assess the kidney and extract the stone.&#xD;
  &#xD;
          2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter)&#xD;
             standard tube to assess the kidney and extract the stone.&#xD;
  &#xD;
        Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the&#xD;
        study will include the day of the surgery and following hospital stay until postoperative&#xD;
        follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Aim 1: Stone free rate</measure>
      <time_frame>6 weeks</time_frame>
      <description>The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aim 2: Intraoperative variables</measure>
      <time_frame>3-7 days</time_frame>
      <description>Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aim 3: Post-operative Outcomes and Complications</measure>
      <time_frame>1 day</time_frame>
      <description>Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Kidney Stone</condition>
    <arm_group>
      <arm_group_label>vacuum-assisted sheath</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>passive suction via conventional sheath</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>vacuum assisted sheath</intervention_name>
      <description>allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval</description>
      <arm_group_label>vacuum-assisted sheath</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>passive suction via conventional sheath</intervention_name>
      <description>conventional access sheath for stone retrieval using current technique via passive suction</description>
      <arm_group_label>passive suction via conventional sheath</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with planned prone mini-PCNL and a preoperative NCCT&#xD;
  &#xD;
            -  Primary stone size: 10-25 mm&#xD;
  &#xD;
            -  Pre-existing indwelling nephrostomy tube or ureteral stent permitted&#xD;
  &#xD;
            -  Age: ≥ 18 years old&#xD;
  &#xD;
            -  Gender: all&#xD;
  &#xD;
            -  Ethnicity: all&#xD;
  &#xD;
            -  Capable of giving informed consent&#xD;
  &#xD;
            -  Capable and willing to fulfill requirements of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anticoagulated or history of coagulopathy&#xD;
  &#xD;
            -  Congenital renal anomalies&#xD;
  &#xD;
            -  Prior ipsilateral upper urinary tract reconstructive procedures&#xD;
  &#xD;
            -  Conversion to open procedure&#xD;
  &#xD;
            -  Multiple access tracts&#xD;
  &#xD;
            -  Inability to give informed consent or unable to meet requirements of the study for any&#xD;
               reason&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Kidney Calculi</mesh_term>
      <mesh_term>Nephrolithiasis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993546
  org study id: 23-104
  nct id: NCT05993546
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to compare two variations of the mini-PCNL procedure using
        either a vacuum-assisted sheath or standard sheath which are both used for the surgical
        treatment of kidney stones. Both procedure types are commonly used in the treatment of
        kidneys stones and they have been shown to be safe and effective in the treatment of stones
        similar in size and location to your own.
  In this study we aim to compare two variations of the miniaturized percutaneous
        nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of
        kidney stones. This procedure involves accessing the kidney via a small temporary tract that
        is placed through the patient's back during surgery. Both procedure types are commonly used
        in the treatment of kidneys stones and they have been shown to be safe and effective in the
        treatment of stones similar in size and location to your own.
  
        Two procedure types will be investigated:
  
          1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter)
             vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
  
          2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter)
             standard tube to assess the kidney and extract the stone.
  
        Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the
        study will include the day of the surgery and following hospital stay until postoperative
        follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Aim 1: Stone free rate
  time frame: 6 weeks
  description: The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray
  measure: Aim 2: Intraoperative variables
  time frame: 3-7 days
  description: Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL
  measure: Aim 3: Post-operative Outcomes and Complications
  time frame: 1 day
  description: Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS
  arm group label: vacuum-assisted sheath
  arm group type: Active Comparator
  arm group label: passive suction via conventional sheath
  arm group type: Active Comparator
  intervention type: Device
  intervention name: vacuum assisted sheath
  description: allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
  arm group label: vacuum-assisted sheath
  intervention type: Device
  intervention name: passive suction via conventional sheath
  description: conventional access sheath for stone retrieval using current technique via passive suction
  arm group label: passive suction via conventional sheath
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Kidney Calculi
  mesh term: Nephrolithiasis