<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/NCT01703143</url>
  </required_header>
  <id_info>
    <org_study_id>10-007909</org_study_id>
    <nct_id>NCT01703143</nct_id>
  </id_info>
  <brief_title>Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy</brief_title>
  <official_title>A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with&#xD;
      focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and&#xD;
      safe minimally invasive technique for control of seizures in such patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, we propose to evaluate a novel, thermal therapy and feedback system&#xD;
      (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment&#xD;
      of focal lesional epilepsy in patients that are considered high risk surgical candidates.&#xD;
      This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which&#xD;
      allows delivery of laser energy while the patient is being imaged by an MRI unit. The&#xD;
      Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the&#xD;
      thermal dose delivered to the target, resulting in a more precise and controlled delivery&#xD;
      which has heretofore not been possible with previous non-image guided laser technology. We&#xD;
      hypothesize that the Visualase system can be used in patients refractory to medication&#xD;
      therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the&#xD;
      brain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1</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>The number of seizures recorded in seizure diary</measure>
    <time_frame>Baseline to 1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Laser Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser ablation of focal lesions in patients with medically refractory partial epilepsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser ablation</intervention_name>
    <description>Laser ablation of focal lesions in patients with medically refractory partial epilepsy.</description>
    <arm_group_label>Laser Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older at entry to protocol.&#xD;
&#xD;
          -  History of MRI lesional-related epilepsy for at least one year.&#xD;
&#xD;
          -  Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration.&#xD;
&#xD;
          -  Candidate for resective epilepsy surgery.&#xD;
&#xD;
          -  Considered healthy enough to undergo surgery with general anesthesia.&#xD;
&#xD;
          -  The patient has given written informed consent after the nature of the study and&#xD;
             alternative treatment options have been explained.&#xD;
&#xD;
          -  Must have 3 months of seizure frequency recorded prior to procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any non-MRI compatible implanted electronic device.&#xD;
&#xD;
          -  Presence of a metallic prosthetic or implant including artificial hips, knees, joints,&#xD;
             or rods and screws.&#xD;
&#xD;
          -  Active Major depression&#xD;
&#xD;
          -  History of Suicide attempts&#xD;
&#xD;
          -  History of Non-Epileptic Behavioral Spells&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W Marsh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>January 23, 2015</last_update_submitted>
  <last_update_submitted_qc>January 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>W. Richard Marsh</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsies, Partial</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/NCT01703143
org study id: 10-007909
nct id: NCT01703143
lead sponsor: 
has dmc: Yes
To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with
      focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and
      safe minimally invasive technique for control of seizures in such patients.
In this study, we propose to evaluate a novel, thermal therapy and feedback system
      (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment
      of focal lesional epilepsy in patients that are considered high risk surgical candidates.
      This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which
      allows delivery of laser energy while the patient is being imaged by an MRI unit. The
      Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the
      thermal dose delivered to the target, resulting in a more precise and controlled delivery
      which has heretofore not been possible with previous non-image guided laser technology. We
      hypothesize that the Visualase system can be used in patients refractory to medication
      therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the
      brain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of seizures recorded in seizure diary
time frame: Baseline to 1 year
arm group label: Laser Ablation
arm group type: Experimental
description: Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
intervention type: Procedure
intervention name: Laser ablation
description: Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
arm group label: Laser Ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: W Marsh, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: W. Richard Marsh
investigator title: Principle Investigator
mesh term: Epilepsy
mesh term: Epilepsies, Partial