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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

A

Ascension South East Michigan

Status

Completed

Conditions

Vestibular Schwannoma
Cochlear Implantation

Treatments

Device: Cochlear implant

Study type

Interventional

Funder types

Other

Identifiers

NCT03958006
1349609

Details and patient eligibility

About

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Full description

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Enrollment

6 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Cochlear implantation
Experimental group
Description:
Simultaneous cochlear implantation with tumor resection
Treatment:
Device: Cochlear implant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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