<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/NCT03751085</url>
  </required_header>
  <id_info>
    <org_study_id>NMRR-17-3247-36799</org_study_id>
    <nct_id>NCT03751085</nct_id>
  </id_info>
  <brief_title>A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain</brief_title>
  <acronym>AWF</acronym>
  <official_title>A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health, Malaysia</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 establish a new, alternative stereotactic biopsy frame (AW frame) in the&#xD;
      field of stereotactic neurosurgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study&#xD;
      had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good&#xD;
      accuracy. The phantom study result is going to be submitted for publication by early 2019.&#xD;
&#xD;
      With the good accuracy of AW frame in the phantom study, the frame has been approved by the&#xD;
      Medical Research &amp; ethic committee (MREC) for human use in a research setting.&#xD;
&#xD;
      In the study, patient with intracranial lesion which required biopsy, whom fulfilled the&#xD;
      criteria will be recruited. All these patient will underwent standard biopsy procedure either&#xD;
      under local or general anaesthesia with AW frame mounted.&#xD;
&#xD;
      A localisation CT scanning will be perform with localiser fixed onto the head frame. Target&#xD;
      of the intracranial lesion is selected. The coordinates of the localizing points and the&#xD;
      selected target inserted into the AW stereo-calculator to generate the AW frame setting up&#xD;
      measurements.&#xD;
&#xD;
      Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate&#xD;
      post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be&#xD;
      monitored in the neurosurgery ward for any complications.&#xD;
&#xD;
      Histopathologic analysis of the biopsies will be done using usual procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 17, 2020</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic yield</measure>
    <time_frame>For each patient 2 week after the biopsy</time_frame>
    <description>The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants presenting with post-biopsy complications</measure>
    <time_frame>an average of 2 week</time_frame>
    <description>The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time</measure>
    <time_frame>From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.</time_frame>
    <description>the preparation, operation and total operating room time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>an average of 1 week</time_frame>
    <description>The preoperative, postoperative and total length of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Intracranial CNS Disorder</condition>
  <arm_group>
    <arm_group_label>AW frame</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AW frame biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AW frame</intervention_name>
    <description>AW stereotactic frame for intracranial lesion biopsy</description>
    <arm_group_label>AW frame</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;17 years old&#xD;
&#xD;
          -  Radiological diagnosis of intracranial space occupying lesion of any etiology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient involved in other study trial&#xD;
&#xD;
          -  Any serious medical condition that according to the investigator could interfere with&#xD;
             the conduct of the study&#xD;
&#xD;
          -  Unwillingness or inability to comply with study requirements&#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_contact>
    <last_name>Bik Liang Lau, MD</last_name>
    <phone>+60128822977</phone>
    <email>laubikliang@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Albert Sii Hieng Wong, FRACS</last_name>
    <phone>+60128899863</phone>
    <email>wonghm96@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Neurosurgery, Sarawak General Hospital</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bik Liang Lau, MD</last_name>
      <phone>+60128822977</phone>
      <email>laubikliang@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Albert Sii Hieng Wong, FRACS</last_name>
      <phone>+60128899863</phone>
      <email>wonghm96@yahoo.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Miri</name>
      <address>
        <city>Miri</city>
        <state>Sarawak</state>
        <zip>98000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bik Liang Lau, MD</last_name>
      <phone>+60128822977</phone>
      <email>laubikliang@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Albert Sii Hieng Wong, FRACS</last_name>
      <phone>+60128899863</phone>
      <email>wonghm96@yahoo.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Department of Neurosurgery, Hospital Sibu</name>
      <address>
        <city>Sibu</city>
        <state>Sarawak</state>
        <zip>96000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bik Liang Lau, MD</last_name>
      <phone>+60128822977</phone>
      <email>laubikliang@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Albert Sii Hieng Wong, FRACS</last_name>
      <phone>+60128899863</phone>
      <email>wonghm96@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Adrian Wei Chih Ng, Master Neurosurgery</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Malaysia</investigator_affiliation>
    <investigator_full_name>Lau Bik Liang</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>AW frame</keyword>
  <keyword>biopsy</keyword>
  <keyword>stereotactic</keyword>
  <keyword>accuracy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</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/NCT03751085
org study id: NMRR-17-3247-36799
nct id: NCT03751085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the
      field of stereotactic neurosurgery.
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study
      had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good
      accuracy. The phantom study result is going to be submitted for publication by early 2019.

      With the good accuracy of AW frame in the phantom study, the frame has been approved by the
      Medical Research & ethic committee (MREC) for human use in a research setting.

      In the study, patient with intracranial lesion which required biopsy, whom fulfilled the
      criteria will be recruited. All these patient will underwent standard biopsy procedure either
      under local or general anaesthesia with AW frame mounted.

      A localisation CT scanning will be perform with localiser fixed onto the head frame. Target
      of the intracranial lesion is selected. The coordinates of the localizing points and the
      selected target inserted into the AW stereo-calculator to generate the AW frame setting up
      measurements.

      Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate
      post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be
      monitored in the neurosurgery ward for any complications.

      Histopathologic analysis of the biopsies will be done using usual procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic yield
time frame: For each patient 2 week after the biopsy
description: The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.
measure: Number of participants presenting with post-biopsy complications
time frame: an average of 2 week
description: The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.
measure: Time
time frame: From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.
description: the preparation, operation and total operating room time
measure: Length of hospital stay
time frame: an average of 1 week
description: The preoperative, postoperative and total length of hospital stay
arm group label: AW frame
arm group type: Experimental
description: AW frame biopsy
intervention type: Device
intervention name: AW frame
description: AW stereotactic frame for intracranial lesion biopsy
arm group label: AW frame
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bik Liang Lau, MD
phone: +60128822977
email: laubikliang@gmail.com
last name: Albert Sii Hieng Wong, FRACS
phone: +60128899863
email: wonghm96@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Malaysia
investigator full name: Lau Bik Liang
investigator title: Dr.
mesh term: Brain Diseases
sharing ipd: No