Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Auditory Nerve Test System (ANTS) is a novel device that stimulates the auditory nerve much like a cochlear implant. The purpose of this study is to demonstrate feasibility of the ANTS during translabyrinthine surgery for vestibular schwannoma resection. If the auditory nerve is kept intact, then the patients will also receive a cochlear implant at the same time potentially alleviating the morbidities caused by a vestibular schwannoma and asymmetric sensorineural hearing loss.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Vestibular schwannoma (sporadic or Neurofibromastosis Type-2)

• 12 years of age or older

• Tumor size \< 2.5 cm

• Non-serviceable ipsilateral hearing

• No prior cochlear implant or auditory brainstem implant use

• No prior microsurgery or stereotactic radiation for this tumor

• Patient decision and medical clearance for a translabyrinthine approach for tumor resection

• Willingness to comply with research protocol

• Reasonable expectations of cochlear implant performance

• Auditory nerve integrity visually confirmed following tumor resection

Locations
United States
Missouri
Washington University
Saint Louis
Time Frame
Start Date: 2020-01-20
Completion Date: 2023-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Intervention Group
Patients undergoing a translabyrinthine approach for vestibular schwannoma resection will have the health of their auditory nerve monitored during tumor dissection. If the auditory nerve is visually confirmed to be intact, then concurrent cochlear implantation will be performed.
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov