- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011867
A New Cochlear Implant Electrode For Inner Ear Malformations
A New Cochlear Implant Electrode With A "Cork" Type Stopper For Inner Ear Malformations
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have an inner ear malformation
- Must meet the criteria for cochlear implantation
Exclusion Criteria:
- Prior cochlear implantation surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cork Electrode
Using Cork Electrode for CSF leak prevention for inner ear malformations.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CSF leak
Time Frame: Up to 1 year
|
Occurrence of CSF leak after the surgery.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meningitis
Time Frame: Up to 1 year
|
Having meningitis due to CSF leak or connection to the middle ear after surgery.
|
Up to 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hearing
Time Frame: Until death
|
Improvement in hearing after cochlear implantation.
|
Until death
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO-13/315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inner Ear Malformations
-
Simbec ResearchSensorion SACompletedInner Ear Diseases
-
XOMA (US) LLCNational Institute on Deafness and Other Communication Disorders (NIDCD); Feinstein...CompletedAutoimmune Inner Ear DiseaseUnited States
-
Northwell HealthSwedish Orphan BiovitrumRecruitingMeniere's Disease | Autoimmune Inner Ear DiseaseUnited States
-
Eytan A. DavidActive, not recruitingDizziness | Equilibrium; Disorder, Labyrinth | Inner Ear Injury | Inner Ear DiseaseCanada
-
House Research InstituteJanssen Services, LLCTerminatedAutoimmune Inner Ear Disease
-
National Institute on Deafness and Other Communication...RecruitingMeniere's Disease | Enlarged Vestibular Aqueduct Syndrome | Autoimmune Inner Ear DiseaseUnited States
-
Andrea VambutasNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedSensorineural Hearing Loss | Autoimmune Inner Ear DiseaseUnited States
-
Simbec ResearchSensorionCompleted
-
Universidad de ZaragozaAragon Institute of Health SciencesCompletedEquilibrium; Disorder, Labyrinth | Spatial Navigation | Inner Ear DiseaseSpain
-
University Hospital, GrenobleNot yet recruitingInner Ear ; Meniere's Disease; Imaging
Clinical Trials on Cork Electrode
-
Sint MaartenskliniekCompletedLower Limb Amputation Below Knee (Injury)
-
University Hospital, GhentCompletedWounds and Injuries | Ankle Fractures | Wrist Fractures | Elbow Fractures | Forearm Fractures | Foot FracturesBelgium
-
East Carolina UniversityTerminated
-
ConvaTec Inc.Unknown
-
RetMap, IncUniversity of Illinois at Chicago; Illinois College of OptometryActive, not recruitingElectrode Site ReactionUnited States
-
Mayo ClinicUniversity of MinnesotaWithdrawn
-
Erasmus Medical CenterNot yet recruiting
-
McMaster UniversityRecruitingAtrial Fibrillation | Atrial FlutterCanada
-
Seoul National University HospitalRF medical; Medical Research Collaborating CenterCompleted
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AV; General Hospital Groeninge; Universiteit AntwerpenRecruiting