NCT03958006

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vestibular Schwannoma
• Cochlear Implantation

Interventions

Type	Name	Description
DEVICE	Cochlear implant	Tumor resection with cochlear implant

Timeline

• Start date: 2018-12-05
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2019-05-21
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study