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A New Cochlear Implant Electrode For Inner Ear Malformations

Primary Purpose

Inner Ear Malformations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cork Electrode
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inner Ear Malformations focused on measuring Inner Ear Malformations, Gusher, Cochlear Implantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have an inner ear malformation
  • Must meet the criteria for cochlear implantation

Exclusion Criteria:

  • Prior cochlear implantation surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cork Electrode

    Arm Description

    Using Cork Electrode for CSF leak prevention for inner ear malformations.

    Outcomes

    Primary Outcome Measures

    CSF leak
    Occurrence of CSF leak after the surgery.

    Secondary Outcome Measures

    Meningitis
    Having meningitis due to CSF leak or connection to the middle ear after surgery.

    Full Information

    First Posted
    November 30, 2013
    Last Updated
    December 9, 2013
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02011867
    Brief Title
    A New Cochlear Implant Electrode For Inner Ear Malformations
    Official Title
    A New Cochlear Implant Electrode With A "Cork" Type Stopper For Inner Ear Malformations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The custom made device was produced by Med-El Company. It has a "cork" like stopper instead of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations. Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. Another patient had slow extrusion of the electrode most probably due to CSF (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula. CSF fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. The new cochlear implant electrode with "cork" stopper looks promising in preventing the postoperative CSF leak around the electrode.
    Detailed Description
    Gusher in inner ear malformations is common in patients with incomplete partition type-I, and III. It is also common in less severe form as oozing in incomplete partition type II and large vestibular aqueduct. It is important to prevent CSF escape around the cochlear implant electrode to prevent meningitis. The custom made device was produced by Med-El Company. It has a "cork" like stopper instead of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations. Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. Another patient had slow extrusion of the electrode most probably due to CSF pulsation and had to be revised. Both patients had no more CSF fistula. CSF fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. The new cochlear implant electrode with "cork" stopper looks promising in preventing the postoperative CSF leak around the electrode.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inner Ear Malformations
    Keywords
    Inner Ear Malformations, Gusher, Cochlear Implantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cork Electrode
    Arm Type
    Experimental
    Arm Description
    Using Cork Electrode for CSF leak prevention for inner ear malformations.
    Intervention Type
    Device
    Intervention Name(s)
    Cork Electrode
    Other Intervention Name(s)
    MedEl Cork Electrode
    Primary Outcome Measure Information:
    Title
    CSF leak
    Description
    Occurrence of CSF leak after the surgery.
    Time Frame
    Up to 1 year
    Secondary Outcome Measure Information:
    Title
    Meningitis
    Description
    Having meningitis due to CSF leak or connection to the middle ear after surgery.
    Time Frame
    Up to 1 year
    Other Pre-specified Outcome Measures:
    Title
    Hearing
    Description
    Improvement in hearing after cochlear implantation.
    Time Frame
    Until death

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have an inner ear malformation Must meet the criteria for cochlear implantation Exclusion Criteria: Prior cochlear implantation surgery

    12. IPD Sharing Statement

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    A New Cochlear Implant Electrode For Inner Ear Malformations

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