<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/NCT04450797</url>
  </required_header>
  <id_info>
    <org_study_id>2019-02157; ch20Leu</org_study_id>
    <nct_id>NCT04450797</nct_id>
  </id_info>
  <brief_title>Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement</brief_title>
  <acronym>NaVPS</acronym>
  <official_title>Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt&#xD;
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the&#xD;
      surgical intervention time as primary outcome. All patients entering the University Hospital&#xD;
      of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the&#xD;
      study groups at admission or the day before the operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in&#xD;
      neurosurgical practice. The position of the proximal ventricular catheter is important since&#xD;
      it influences possible malfunction of the VPS. For the improvement of accuracy in proximal&#xD;
      VPS placement, navigation-based insertion techniques have been developed. VPS placement using&#xD;
      stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS&#xD;
      placement using stereotactic navigation has shown a high accuracy of catheter placement,&#xD;
      while the main limitations are that for referencing, the head of the patient needs to be&#xD;
      fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement&#xD;
      using a burr hole probe was described as an alternate for image-guided VPS placement&#xD;
      technique. For US-G VPS placement head fixation or preoperative registration is not needed.&#xD;
      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt&#xD;
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the&#xD;
      surgical intervention time as primary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 26, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The primary outcome is the surgical intervention time, recorded by blinded anaesthesiologists. Some of the secondary outcomes (catheter placement (optimal vs. not optimal, grade I to IV), volumetry of side ventricles, Evans' Index) are measured by a blinded neuroradiologist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>surgical intervention time (minutes)</measure>
    <time_frame>at Operation day (V2, up to 24 hours)</time_frame>
    <description>time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning (&quot;positioning&quot;) and ending (&quot;suture neurosurgical part&quot;) of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operation time (minutes)</measure>
    <time_frame>at Operation day (V2, up to 24 hours)</time_frame>
    <description>Operation time (minutes): time in minutes from &quot;cut&quot; to &quot;suture&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaesthesia time (minutes)</measure>
    <time_frame>at Operation day (V2, up to 24 hours)</time_frame>
    <description>Anaesthesia time (minutes): time in minutes from &quot;start anaesthesia&quot; to &quot;end anaesthesia&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of puncture attempts</measure>
    <time_frame>at Operation day (V2, up to 24 hours)</time_frame>
    <description>Number of puncture attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter placement (optimal vs. not optimal)</measure>
    <time_frame>at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6)</time_frame>
    <description>Optimal catheter Placement: free-floating within the Cerebrospinal fluid (CSF) without touching ventricle wall or septum pellucidum, and the tip of the catheter located at the foramen of Monro showing an optimal length of the catheter. Catheters that did not fulfill all criteria have been defined as not optimal placed. Positioning of catheters will be further graded according to Yim et al. into grades I to IV (grade I: catheter terminates in the ipsilateral frontal horn, grade II: catheter terminates in contralateral frontal horn, grade III: catheter terminates in non-targeted CSF spaces, grade IV: catheter terminates intraparenchymally)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in volumetry of side ventricles</measure>
    <time_frame>1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)</time_frame>
    <description>Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Evan's Index</measure>
    <time_frame>before Operation day (V1) and 2-3 days post-op. (V3)</time_frame>
    <description>Change in Evan's Index pre- and postoperatively (number and relative change).The Evans' index is the ratio of maximum width of the frontal horns of the lateral ventricles and the maximal internal diameter of the skull at the same level employed in axial CT images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of complications (infection, bleeding, complications associated with navigation method)</measure>
    <time_frame>from Operation day (V2, up to 24 hours) until 6 months postop. (V6)</time_frame>
    <description>rate of complications (infection, bleeding, complications associated with navigation method)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>from Operation day (V2, up to 24 hours) until 6 months postop. (V6)</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>revision surgery (yes/no)</measure>
    <time_frame>from Operation day (V2,up to 24 hours) until 6 months postop. (V6)</time_frame>
    <description>revision surgery (yes/no)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Ventriculoperitoneal Shunt (VPS)</condition>
  <condition>Hydrocephalus</condition>
  <arm_group>
    <arm_group_label>US -G VPS placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stereotactic navigation for VPS placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).</intervention_name>
    <description>US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).&#xD;
Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance.</description>
    <arm_group_label>US -G VPS placement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).</intervention_name>
    <description>Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).&#xD;
Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet.</description>
    <arm_group_label>Stereotactic navigation for VPS placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
          -  Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision surgery due to former VPS placement using the same side and location for VPS&#xD;
             placement or when no complete shunt is revised (proximal and distal), resulting in a&#xD;
             shorter operation time&#xD;
&#xD;
          -  Ventriculoatrial or ventriculopleural Placement&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Intention to become pregnant during the course of the study&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees, and other dependent&#xD;
             persons&#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>Severina Leu, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosurgery, University Hospital of Basel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luigi Mariani, Prof. Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Neurosurgery, University Hospital of Basel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Severina Leu, Dr. med.</last_name>
    <phone>0041 76 537 84 28</phone>
    <email>Severina.Leu@usb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jehuda Soleman, PD Dr. med.</last_name>
    <phone>0041 78 623 44 88</phone>
    <email>Jehuda.Soleman@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Neurosurgery, University Hospital of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Severina Leu, Dr. med.</last_name>
      <phone>0041 76 537 84 28</phone>
      <email>Severina.Leu@usb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Claudia Huck</last_name>
      <phone>0041 61 328 79 23</phone>
      <email>Claudia.huck@usb.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Jehuda Soleman, PD Dr. med</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ventriculoperitoneal shunt (VPS)-dependency</keyword>
  <keyword>VPS placement</keyword>
  <keyword>Stereotactic Navigated Ventriculoperitoneal Shunt Placement</keyword>
  <keyword>Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</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/NCT04450797
org study id: 2019-02157; ch20Leu
nct id: NCT04450797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome. All patients entering the University Hospital
      of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the
      study groups at admission or the day before the operation.
Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in
      neurosurgical practice. The position of the proximal ventricular catheter is important since
      it influences possible malfunction of the VPS. For the improvement of accuracy in proximal
      VPS placement, navigation-based insertion techniques have been developed. VPS placement using
      stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS
      placement using stereotactic navigation has shown a high accuracy of catheter placement,
      while the main limitations are that for referencing, the head of the patient needs to be
      fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement
      using a burr hole probe was described as an alternate for image-guided VPS placement
      technique. For US-G VPS placement head fixation or preoperative registration is not needed.
      This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt
      (VPS) placement to stereotactic navigation in a randomized controlled fashion with the
      surgical intervention time as primary outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: The primary outcome is the surgical intervention time, recorded by blinded anaesthesiologists. Some of the secondary outcomes (catheter placement (optimal vs. not optimal, grade I to IV), volumetry of side ventricles, Evans' Index) are measured by a blinded neuroradiologist.
measure: surgical intervention time (minutes)
time frame: at Operation day (V2, up to 24 hours)
description: time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning ("positioning") and ending ("suture neurosurgical part") of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.
measure: Operation time (minutes)
time frame: at Operation day (V2, up to 24 hours)
description: Operation time (minutes): time in minutes from "cut" to "suture"
measure: Anaesthesia time (minutes)
time frame: at Operation day (V2, up to 24 hours)
description: Anaesthesia time (minutes): time in minutes from "start anaesthesia" to "end anaesthesia"
measure: Number of puncture attempts
time frame: at Operation day (V2, up to 24 hours)
description: Number of puncture attempts
measure: Catheter placement (optimal vs. not optimal)
time frame: at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6)
description: Optimal catheter Placement: free-floating within the Cerebrospinal fluid (CSF) without touching ventricle wall or septum pellucidum, and the tip of the catheter located at the foramen of Monro showing an optimal length of the catheter. Catheters that did not fulfill all criteria have been defined as not optimal placed. Positioning of catheters will be further graded according to Yim et al. into grades I to IV (grade I: catheter terminates in the ipsilateral frontal horn, grade II: catheter terminates in contralateral frontal horn, grade III: catheter terminates in non-targeted CSF spaces, grade IV: catheter terminates intraparenchymally)
measure: Change in volumetry of side ventricles
time frame: 1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)
description: Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)
measure: Change in Evan's Index
time frame: before Operation day (V1) and 2-3 days post-op. (V3)
description: Change in Evan's Index pre- and postoperatively (number and relative change).The Evans' index is the ratio of maximum width of the frontal horns of the lateral ventricles and the maximal internal diameter of the skull at the same level employed in axial CT images.
measure: rate of complications (infection, bleeding, complications associated with navigation method)
time frame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
description: rate of complications (infection, bleeding, complications associated with navigation method)
measure: mortality
time frame: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)
description: mortality
measure: revision surgery (yes/no)
time frame: from Operation day (V2,up to 24 hours) until 6 months postop. (V6)
description: revision surgery (yes/no)
arm group label: US -G VPS placement
arm group type: Active Comparator
arm group label: Stereotactic navigation for VPS placement
arm group type: Active Comparator
intervention type: Device
intervention name: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
description: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance.
arm group label: US -G VPS placement
intervention type: Device
intervention name: Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
description: Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet.
arm group label: Stereotactic navigation for VPS placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Severina Leu, Dr. med.
role: Principal Investigator
affiliation: Department of Neurosurgery, University Hospital of Basel
last name: Luigi Mariani, Prof. Dr. med.
role: Study Director
affiliation: Department of Neurosurgery, University Hospital of Basel
last name: Severina Leu, Dr. med.
phone: 0041 76 537 84 28
email: Severina.Leu@usb.ch
last name: Jehuda Soleman, PD Dr. med.
phone: 0041 78 623 44 88
email: Jehuda.Soleman@usb.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hydrocephalus