<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/NCT02991352</url>
  </required_header>
  <id_info>
    <org_study_id>3193</org_study_id>
    <secondary_id>2016-00827</secondary_id>
    <nct_id>NCT02991352</nct_id>
  </id_info>
  <brief_title>Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study</brief_title>
  <acronym>SIGVaM</acronym>
  <official_title>Stereotactic MRI Based Image Guidance for the Treatment of Vascular Malformations - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Treatment of vascular malformations requires the placement of a needle within anatomically&#xD;
      non well defined, pathological vessels, which may be as small as 1 mm, with the current state&#xD;
      of the art relying exclusively on two dimensional fluoroscopy images for guidance. The&#xD;
      investigators hypothesize that the combination of stereotactic image guidance with existing&#xD;
      targeting methods will result in faster and more reproducible needle placements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study aims to investigate the feasibility of the utilization of stereotactic&#xD;
      image guidance technology for the needle based percutaneous treatment of peripheral vascular&#xD;
      malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use&#xD;
      with needle based procedures in combination with medical image data including MRI data, as&#xD;
      required by this study.&#xD;
&#xD;
      Utilizing feedback from the stereotactic image guidance system, the interventionalist will&#xD;
      attempt to place the needle within the malformation. The position and orientation of the&#xD;
      needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as&#xD;
      relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The&#xD;
      position of the needle relative to the desired position within the malformation will be&#xD;
      evaluated utilizing fluoroscopy.&#xD;
&#xD;
      If necessary the position of the needle will be adjusted, this adjustment can be performed&#xD;
      utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the&#xD;
      physician. The final position of the needle will be confirmed on intra-operative DSA imaging&#xD;
      and the sclerosant will be applied according to standard clinical protocols.&#xD;
&#xD;
      This single-centre pilot study will involve a total of 10 patients suffering from peripheral&#xD;
      vascular malformations. Only non-emergency adult patients will be considered for inclusion in&#xD;
      this trial. Inclusion will be at the discretion of the treating physician and patient. As the&#xD;
      study is designed as a pilot trial, no comparator is considered and no blinding performed.&#xD;
      The trial will be performed over a period of nine months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to reach the target</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Time from start of targeting to alcohol embolization in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation time</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Measured by the C-arm imaging device in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation dose</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Measured by the C-arm imaging device in μGym²</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast agent volume</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Measured by the nurses in milliliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Defined as number of skin punctures, counted by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason to change to standard approach</measure>
    <time_frame>During the intervention (duration approx. 90 minutes on average)</time_frame>
    <description>Asked by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Usability Score (SUS)</measure>
    <time_frame>Directly after the intervention (60 minutes afterwards at the latest)</time_frame>
    <description>Filled out by the interventionalist</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vascular Malformations</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Image guided needle placement into vascular malformations based on MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Image guided needle placement</intervention_name>
    <description>Stereotactic MRI based image guidance to aid in the placement of percutaneous needles into vascular malformations using a CE marked navigation system (CAS-One IR, CAScination AG)</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with venous or mixed venous-lymphatic malformation&#xD;
&#xD;
          -  Patients which are regular scheduled for a percutaneous treatment of a vascular&#xD;
             malformation&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#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>Iris Baumgartner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ARTORG Center for Biomedical Engineering</name>
      <address>
        <city>Bern</city>
        <zip>3008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Angiologie</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular Malformations</keyword>
  <keyword>Image Guidance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Malformations</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT02991352
org study id: 3193
secondary id: 2016-00827
nct id: NCT02991352
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of vascular malformations requires the placement of a needle within anatomically
      non well defined, pathological vessels, which may be as small as 1 mm, with the current state
      of the art relying exclusively on two dimensional fluoroscopy images for guidance. The
      investigators hypothesize that the combination of stereotactic image guidance with existing
      targeting methods will result in faster and more reproducible needle placements.
This prospective study aims to investigate the feasibility of the utilization of stereotactic
      image guidance technology for the needle based percutaneous treatment of peripheral vascular
      malformations. The specific device to be utilized is the CAS-One IR system, CE marked for use
      with needle based procedures in combination with medical image data including MRI data, as
      required by this study.

      Utilizing feedback from the stereotactic image guidance system, the interventionalist will
      attempt to place the needle within the malformation. The position and orientation of the
      needle relative to the anatomy will be displayed on 2D slices from the MRI, as well as
      relative to a 3D volume rendering of the patient anatomy constructed from MRI data. The
      position of the needle relative to the desired position within the malformation will be
      evaluated utilizing fluoroscopy.

      If necessary the position of the needle will be adjusted, this adjustment can be performed
      utilizing navigated feedback or standard fluoroscopy feedback at the discretion of the
      physician. The final position of the needle will be confirmed on intra-operative DSA imaging
      and the sclerosant will be applied according to standard clinical protocols.

      This single-centre pilot study will involve a total of 10 patients suffering from peripheral
      vascular malformations. Only non-emergency adult patients will be considered for inclusion in
      this trial. Inclusion will be at the discretion of the treating physician and patient. As the
      study is designed as a pilot trial, no comparator is considered and no blinding performed.
      The trial will be performed over a period of nine months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to reach the target
time frame: During the intervention (duration approx. 90 minutes on average)
description: Time from start of targeting to alcohol embolization in minutes
measure: Radiation time
time frame: During the intervention (duration approx. 90 minutes on average)
description: Measured by the C-arm imaging device in seconds
measure: Radiation dose
time frame: During the intervention (duration approx. 90 minutes on average)
description: Measured by the C-arm imaging device in μGym²
measure: Contrast agent volume
time frame: During the intervention (duration approx. 90 minutes on average)
description: Measured by the nurses in milliliter
measure: Number of attempts
time frame: During the intervention (duration approx. 90 minutes on average)
description: Defined as number of skin punctures, counted by the investigator
measure: Reason to change to standard approach
time frame: During the intervention (duration approx. 90 minutes on average)
description: Asked by the investigator
measure: System Usability Score (SUS)
time frame: Directly after the intervention (60 minutes afterwards at the latest)
description: Filled out by the interventionalist
arm group label: Experimental
arm group type: Experimental
description: Image guided needle placement into vascular malformations based on MRI
intervention type: Device
intervention name: Image guided needle placement
description: Stereotactic MRI based image guidance to aid in the placement of percutaneous needles into vascular malformations using a CE marked navigation system (CAS-One IR, CAScination AG)
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iris Baumgartner, MD
role: Principal Investigator
affiliation: Insel Gruppe AG, University Hospital Bern
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Vascular Malformations
mesh term: Congenital Abnormalities
sharing ipd: No