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
About this trial
This is an interventional treatment trial for Inner Ear Malformations focused on measuring Inner Ear Malformations, Gusher, Cochlear Implantation
Eligibility Criteria
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
NCT ID
NCT02011867
First Posted
November 30, 2013
Last Updated
December 9, 2013
Sponsor
Hacettepe University
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
Learn more about this trial
A New Cochlear Implant Electrode For Inner Ear Malformations
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