Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage

Neurovalens Ltd.1 site in 1 country25 target enrollmentMarch 4, 2021

ConditionsSafety Issues

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Safety Issues
Sponsor: Neurovalens Ltd.
Enrollment: 25
Locations: 1
Primary Endpoint: Assessment of hearing function as reported by formal audiometry testing
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

Detailed Description

A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.

Registry

clinicaltrials.gov

Start Date

March 4, 2021

End Date

July 23, 2021

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Neurovalens Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Vestal DM user (more than 6 months)

Exclusion Criteria

•Vestal DM device user (less than 6 months)

Outcomes

Primary Outcomes

Assessment of hearing function as reported by formal audiometry testing

Time Frame: Baseline

Formal audiometry testing to be conducted using the AMTAS Flex Device

Secondary Outcomes

Frequency of device related adverse events(Baseline)
Otoscope examination of the inside of both ear canals and tympanic membranes(Baseline)
Inspection of the skin behind the ears (mastoid area)(Baseline)