Clinical trial · Interventional
Auditory Nerve Test System During Vestibular Schwannoma Resection
Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acoustic Neuroma | Vestibular Schwannoma | ALIAS | 0.90 |
| Asymmetric Sensorineural Hearing Loss | — | UNRESOLVED | — |
| Auditory; Nerve | — | UNRESOLVED | — |
| Cochlear Nerve Damage | — | UNRESOLVED | — |
| Cochlear Nerve Deafness | — | UNRESOLVED | — |
| Sensorineural Hearing Loss | — | UNRESOLVED | — |
| Skull Base Neoplasms | Skull Base Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auditory Nerve Test System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 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.
- interventionNames
- Device: Auditory Nerve Test System
Primary outcomes (1)
- measure
- Auditory Nerve Electrophysiology
- timeFrame
- Intraoperative testing
- description
- Reliability of electrically-evoked direct auditory nerve monitoring at the brainstem (eCNAP) and far-field auditory brainstem response (eABR). The auditory nerve signal will be monitored before, during, and after vestibular schwannoma resection. Elements like signal amplitude, latency, and preservation of eABR waveforms III and V will be measured.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Pathology/tumors other than a vestibular schwannoma * Younger than 12 years of age * Tumor size \> 2.5 cm * Serviceable hearing in the tumor ear * Prior cochlear implant use in either the contralateral or ipsilateral ear * Prior microsurgery or stereotactic radiation for this tumor * Unwilling to comply with research protocol * Auditory nerve integrity cannot be visually confirmed after tumor resection
References
Publications (0)
Data not yet available