Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

April 18, 2023 updated by: Ascension South East Michigan
This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Seilesh Babu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cochlear implantation
Simultaneous cochlear implantation with tumor resection
Device: Cochlear implant
Tumor resection with cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Hearing Parameters
Time Frame: 1 month, 3 months and 6 months postoperatively.
Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.
1 month, 3 months and 6 months postoperatively.
Measurement of Hearing Parameters
Time Frame: 1 month, 3 months and 6 months postoperatively.
Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.
1 month, 3 months and 6 months postoperatively.
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.
1 month, 3 months and 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Change of Physical Symptoms Associated with Hearing Loss
Time Frame: 1, 3 and 6 months postoperatively
Patients will complete the Dizziness Handicap Inventory
1, 3 and 6 months postoperatively
Assessment of Change of Physical Symptoms Associated with Hearing Loss
Time Frame: 1, 3 and 6 months postoperatively
Patients will complete the Tinnitus Handicap Inventory
1, 3 and 6 months postoperatively
Assessment of incision site healing
Time Frame: 1 week, and 1 and 3 months postoperatively
Surgeon evaluates wound hearing over 3 months
1 week, and 1 and 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension South East Michigan

Investigators

  • Principal Investigator: Seilish Babu, MD, Michigan Ear Institute, Farmington Hills, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1349609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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