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Completed

NCT Number: NCT02011867

A New Cochlear Implant Electrode 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior cochlear implantation surgery

Treatment and study plan

Cork Electrode

Device

Other names: MedEl Cork Electrode

Primary outcomes

  1. CSF leak

    Time frame: Up to 1 year

    Occurrence of CSF leak after the surgery.

Secondary outcomes

  1. Meningitis

    Time frame: Up to 1 year

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

Other outcomes

  1. Hearing

    Time frame: Until death

    Improvement in hearing after cochlear implantation.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

A New Cochlear Implant Electrode With A "Cork" Type Stopper For Inner Ear Malformations

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2013
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.