<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/NCT03228511</url>
  </required_header>
  <id_info>
    <org_study_id>Easpost fossa</org_study_id>
    <nct_id>NCT03228511</nct_id>
  </id_info>
  <brief_title>Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions</brief_title>
  <official_title>Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a Prospective descriptive hospital based clinical study to determine the value of&#xD;
      introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to&#xD;
      estimate the following :&#xD;
&#xD;
        1. Intraoperative judgement of lesions excision, residual parts, visualization and&#xD;
           operative corridor pre and after endoscope introduction.&#xD;
&#xD;
        2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.&#xD;
&#xD;
        3. Postoperative complications, advantages and disadvantages compared with these when use&#xD;
           pure microscopic excision from the literature&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>post operative residual tumor</measure>
    <time_frame>1 week</time_frame>
    <description>post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Cerebellopontine Angle Tumor</condition>
  <arm_group>
    <arm_group_label>Formerly Arm Label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endoscope</intervention_name>
    <description>It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions</description>
    <arm_group_label>Formerly Arm Label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: cerebellopontine angle lesions&#xD;
&#xD;
          -  meningeoma.&#xD;
&#xD;
          -  vestibular schwannoma.&#xD;
&#xD;
          -  arachnoid cyst.&#xD;
&#xD;
          -  petroclival meningeoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  trigeminal neuralgia.&#xD;
&#xD;
          -  facial neuralgia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammad Tamam</investigator_full_name>
    <investigator_title>Principal invistigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroma, Acoustic</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/NCT03228511
org study id: Easpost fossa
nct id: NCT03228511
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is a Prospective descriptive hospital based clinical study to determine the value of
      introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to
      estimate the following :

        1. Intraoperative judgement of lesions excision, residual parts, visualization and
           operative corridor pre and after endoscope introduction.

        2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.

        3. Postoperative complications, advantages and disadvantages compared with these when use
           pure microscopic excision from the literature
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: post operative residual tumor
time frame: 1 week
description: post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts
arm group label: Formerly Arm Label
arm group type: Experimental
intervention type: Device
intervention name: endoscope
description: It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions
arm group label: Formerly Arm Label
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammad Tamam
investigator title: Principal invistigator
mesh term: Neuroma, Acoustic