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Clinical Trials/NCT03958006
NCT03958006
Completed
Not Applicable

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Ascension South East Michigan1 site in 1 country6 target enrollmentDecember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibular Schwannoma
Sponsor
Ascension South East Michigan
Enrollment
6
Locations
1
Primary Endpoint
Measurement of Hearing Parameters
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 5, 2018
End Date
January 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ascension South East Michigan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Measurement of Hearing Parameters

Time Frame: 1 month, 3 months and 6 months postoperatively.

Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.

Secondary Outcomes

  • Measurement of Change of Physical Symptoms Associated with Hearing Loss(1, 3 and 6 months postoperatively)
  • Assessment of Change of Physical Symptoms Associated with Hearing Loss(1, 3 and 6 months postoperatively)
  • Assessment of incision site healing(1 week, and 1 and 3 months postoperatively)

Study Sites (1)

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