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Auditory Nerve Test System During Vestibular Schwannoma Resection

NCT04241679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

  • Vestibular Schwannoma
  • Acoustic Neuroma
  • Sensorineural Hearing Loss
  • Asymmetric Sensorineural Hearing Loss
  • Cochlear Nerve Damage
  • Cochlear Nerve Deafness
  • Skull Base Neoplasms
  • Auditory; Nerve

Interventions

DEVICE

Auditory Nerve Test System

The Auditory Nerve Test System provides an electrically-evoked signal from within the cochlea to facilitate intraoperative auditory nerve monitoring. The auditory nerve can be measured both at the root entry zone of the brainstem (eCNAP) and with scalp electrodes (eABR). Data on the health of the auditory nerve will be collected immediately prior to tumor dissection, during tumor dissection, and immediately after tumor dissection. The main purpose of this study is to determine feasibility of this novel intraoperative monitoring protocol. Secondarily, if the auditory nerve is visually confirmed to be intact following tumor resection then the patients will receive a cochlear implant during the same surgery.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Cameron C Wick, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241679 on ClinicalTrials.gov