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 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma Cochlear Implantation||Device: Cochlear implant||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||November 6, 2020|
|Estimated Study Completion Date :||November 6, 2020|
Experimental: Cochlear implantation
Simultaneous cochlear implantation with tumor resection
Device: Cochlear implant
Tumor resection with cochlear implant
- 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.
- 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.
- 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.
- 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
- 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
- Assessment of incision site healing [ Time Frame: 1 week, and 1 and 3 months postoperatively ]Surgeon evaluates wound hearing over 3 months
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
|Contact: Seilesh Babu, MD||(248) firstname.lastname@example.org|
|Contact: Marianne Lahey, BSN||(248) 465-4828||Marianne.Lahey@ascension.org|
|United States, Michigan|
|Farmington Hills, Michigan, United States, 48334|
|Contact: Seilesh Babu, M.D. 248-865-4444|
|Principal Investigator:||Seilish Babu, MD||Michigan Ear Institute, Farmington Hills, MI|