<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/NCT03261726</url>
  </required_header>
  <id_info>
    <org_study_id>IRB# 1040241</org_study_id>
    <nct_id>NCT03261726</nct_id>
  </id_info>
  <brief_title>Maintaining Cochlear Patency After VIIIth Nerve Surgery</brief_title>
  <official_title>Maintaining Cochlear Patency After VIIIth Nerve Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eric W. Sargent, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Med-El Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ascension South East Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with&#xD;
      progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth&#xD;
      on serial MRI scans typically lead to deafness in the affected ear over time. Radiation&#xD;
      (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery&#xD;
      (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small&#xD;
      tumors, although initial hearing preservation by both modalities may fail over time. Surgical&#xD;
      resection via the translabyrinthine approach is the safest way to remove many of these&#xD;
      tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply&#xD;
      (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at&#xD;
      risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies&#xD;
      (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be&#xD;
      required later. The incidence of this is 46% in our patients. This study seeks to determine&#xD;
      the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing&#xD;
      translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant&#xD;
      at a later time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects were enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 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>Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode</measure>
    <time_frame>One year postoperatively</time_frame>
    <description>Office visits and MRI monitoring:&#xD;
2 - 3 weeks after surgery: Routine post-operative visit for wound care. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance.&#xD;
3 - 4 months after surgery: Monitoring MRI with and without contrast of the inner ear/internal auditory canals with routine post-operative visit. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.&#xD;
Study Endpoint: 1 year after surgery. Repeat MRI with and without contrast of the inner ear/internal auditory canals. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of fluid in the cochlea</measure>
    <time_frame>3- 4 months and 1 year after tumor removal and implantation of the insertion electrode</time_frame>
    <description>Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acoustic Neuroma</condition>
  <condition>Labyrinthitis Ossificans</condition>
  <condition>Profound Hearing Impairment</condition>
  <arm_group>
    <arm_group_label>MedEl Test Electrode Placer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MedEl Test Electrode Placed at VIIIth nerve tumor resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MedEl Test Electrode Placer</intervention_name>
    <description>This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.</description>
    <arm_group_label>MedEl Test Electrode Placer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients of all ages with unilateral or bilateral acoustic neuromas who face loss of&#xD;
             hearing in 1 ear from surgical removal via a translabyrinthine approach.&#xD;
&#xD;
          -  patients do not meet criteria for conventional cochlear implantation or auditory&#xD;
             brainstem implantation.&#xD;
&#xD;
          -  tumor removal must allow preservation of the auditory division of the VIIIth cranial&#xD;
             nerve.&#xD;
&#xD;
          -  the patient must be willing to undergo preoperative S pneumococcus immunization&#xD;
             protocol recommended by the US CDC immunization recommendations for cochlear implant&#xD;
             patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to preserve the auditory division of the VIIIth cranial nerve during tumor&#xD;
             removal ossification or fibrosis of the cochlea found on preoperative imaging (CT or&#xD;
             MRI) that precludes cochlear implantation.&#xD;
&#xD;
          -  active middle ear disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric W Sargent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ascension Providence Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Michigan Ear Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ascension South East Michigan</investigator_affiliation>
    <investigator_full_name>Eric W. Sargent, MD</investigator_full_name>
    <investigator_title>Clinical Researcher</investigator_title>
  </responsible_party>
  <keyword>unilateral deafness</keyword>
  <keyword>acoustic neuroma</keyword>
  <keyword>cochlear implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroma</mesh_term>
    <mesh_term>Neuroma, Acoustic</mesh_term>
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Labyrinthitis</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/NCT03261726
org study id: IRB# 1040241
nct id: NCT03261726
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with
      progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth
      on serial MRI scans typically lead to deafness in the affected ear over time. Radiation
      (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in ~80% while surgery
      (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small
      tumors, although initial hearing preservation by both modalities may fail over time. Surgical
      resection via the translabyrinthine approach is the safest way to remove many of these
      tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply
      (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at
      risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies
      (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be
      required later. The incidence of this is 46% in our patients. This study seeks to determine
      the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing
      translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant
      at a later time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
time frame: One year postoperatively
description: Office visits and MRI monitoring:
2 - 3 weeks after surgery: Routine post-operative visit for wound care. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance.
3 - 4 months after surgery: Monitoring MRI with and without contrast of the inner ear/internal auditory canals with routine post-operative visit. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.
Study Endpoint: 1 year after surgery. Repeat MRI with and without contrast of the inner ear/internal auditory canals. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.
measure: Presence or absence of fluid in the cochlea
time frame: 3- 4 months and 1 year after tumor removal and implantation of the insertion electrode
description: Appearance of the implanted cochlea on heavily T2-weighted monitoring MRI 3-4 months after surgery and 1 year after surgery.
arm group label: MedEl Test Electrode Placer
arm group type: Experimental
description: MedEl Test Electrode Placed at VIIIth nerve tumor resection
intervention type: Device
intervention name: MedEl Test Electrode Placer
description: This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.
arm group label: MedEl Test Electrode Placer
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eric W Sargent, MD
role: Principal Investigator
affiliation: Ascension Providence Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ascension South East Michigan
investigator full name: Eric W. Sargent, MD
investigator title: Clinical Researcher
mesh term: Neuroma
mesh term: Neuroma, Acoustic
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Labyrinthitis
sharing ipd: No