NCT04241679Completed
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 · Last updated 25 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 5 Nov 2019
- Start date
- 20 Jan 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT04241679
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 20 Jan 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior cochlear implant use in either the contralateral or ipsilateral ear
- Prior microsurgery or stereotactic radiation for this tumor
- Auditory nerve integrity cannot be visually confirmed after tumor resection
Age
- Younger than 12 years of age
Other
- Pathology/tumors other than a vestibular schwannoma
- Tumor size \> 2.5 cm
- Serviceable hearing in the tumor ear
- Unwilling to comply with research protocol
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.