<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/NCT03232385</url>
  </required_header>
  <id_info>
    <org_study_id>CGM 18-001</org_study_id>
    <nct_id>NCT03232385</nct_id>
  </id_info>
  <brief_title>Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)</brief_title>
  <acronym>MANIFOLD I</acronym>
  <official_title>Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clear Guide Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clear Guide Medical</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research is to evaluate functional validation of the MR-US fusion for&#xD;
      the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human subjects are proposed to validate the MR-US fusion aspects of the Clear Guide SCENERGY&#xD;
      product. For these modalities, Clear Guide Medical will work with the subcontract PI to&#xD;
      determine the appropriate clinical procedure to evaluate (1) functional validation of the&#xD;
      fusion system and (2) benefits derived from system performance. The selected procedure must&#xD;
      be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require&#xD;
      approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard&#xD;
      clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide&#xD;
      Medical plans to determine sample size based upon statistical powering for a predetermined&#xD;
      clinically-meaningful difference (delta). This delta has not been selected, because this&#xD;
      depends on the procedure selected. The anticipated sample size is expected to be around 100&#xD;
      subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible.&#xD;
      Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects&#xD;
      will be placed into treatment group by random. Retention strategies are unnecessary, as there&#xD;
      will not be any planned follow-up visits or activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">March 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of Needle Placement</measure>
    <time_frame>Immediately following intervention (within 2 hours)</time_frame>
    <description>Distance between needle position and target</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Renal Biopsy or Ablation</condition>
  <arm_group>
    <arm_group_label>MR-US Fusion Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clear Guide SCENERGY, MR-US</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EM Fusion or No Fusion Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR-US Fusion Arm</intervention_name>
    <description>Use of Clear Guide SCENERGY for MR-US fusion guidance</description>
    <arm_group_label>MR-US Fusion Arm</arm_group_label>
    <other_name>Clear Guide SCENERGY, MR-US</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal Biopsy or Ablation</intervention_name>
    <description>Standard of Care</description>
    <arm_group_label>EM Fusion or No Fusion Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing radiological, oncological, or urological intervention procedures&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Vulnerable populations and children&#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>July 2017</verification_date>
  <study_first_submitted>July 12, 2016</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03232385
org study id: CGM 18-001
nct id: NCT03232385
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this research is to evaluate functional validation of the MR-US fusion for
      the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system
      performance.
Human subjects are proposed to validate the MR-US fusion aspects of the Clear Guide SCENERGY
      product. For these modalities, Clear Guide Medical will work with the subcontract PI to
      determine the appropriate clinical procedure to evaluate (1) functional validation of the
      fusion system and (2) benefits derived from system performance. The selected procedure must
      be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require
      approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard
      clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide
      Medical plans to determine sample size based upon statistical powering for a predetermined
      clinically-meaningful difference (delta). This delta has not been selected, because this
      depends on the procedure selected. The anticipated sample size is expected to be around 100
      subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible.
      Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects
      will be placed into treatment group by random. Retention strategies are unnecessary, as there
      will not be any planned follow-up visits or activities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Success of Needle Placement
time frame: Immediately following intervention (within 2 hours)
description: Distance between needle position and target
arm group label: MR-US Fusion Arm
arm group type: Experimental
description: Clear Guide SCENERGY, MR-US
arm group label: EM Fusion or No Fusion Arm
arm group type: Active Comparator
intervention type: Device
intervention name: MR-US Fusion Arm
description: Use of Clear Guide SCENERGY for MR-US fusion guidance
arm group label: MR-US Fusion Arm
other name: Clear Guide SCENERGY, MR-US
intervention type: Procedure
intervention name: Renal Biopsy or Ablation
description: Standard of Care
arm group label: EM Fusion or No Fusion Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No