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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

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ClinicalTrials.gov Identifier: NCT03958006
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

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

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Cochlear Implantation Device: Cochlear implant Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2019


Arm Intervention/treatment
Experimental: Cochlear implantation
Simultaneous cochlear implantation with tumor resection
Device: Cochlear implant
Tumor resection with cochlear implant




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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

  2. 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

  3. Assessment of incision site healing [ Time Frame: 1 week, and 1 and 3 months postoperatively ]
    Surgeon evaluates wound hearing over 3 months



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958006


Contacts
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Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248) 465-4828 Marianne.Lahey@ascension.org

Locations
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United States, Michigan
Seilesh Babu Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Seilesh Babu, M.D.    248-865-4444      
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Seilish Babu, MD Michigan Ear Institute, Farmington Hills, MI

Publications:

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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT03958006     History of Changes
Other Study ID Numbers: 1349609
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases