Electrical Vestibular Nerve Stimulation (VeNS): A Follow-... | NCT04783883

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

NCT04783883

Sponsor

Neurovalens Ltd.

Status

Completed

Last Update Posted

Jan 17, 2024Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Safety Issues

Interventions

Vestal DM

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2021Actual

Primary Completion Date

Jul 5, 2021Actual

Completion Date

Jul 23, 2021Actual

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2024

Last Update Posted Date

Jan 17, 2024Actual

Name	Class
R D Gardi Medical College, Ujjain	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vestal DM	Device	Battery powered non-invasive neurostimulation device (1.5mA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of hearing function as reported by formal audiometry testing	Formal audiometry testing to be conducted using the AMTAS Flex Device	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Frequency of device related adverse events		Baseline
Inspection of the skin behind the ears (mastoid area)	Photographic inspection of the skin behind the ears to confirm no skin irritation has been caused at the mastoid area where the electrode pads are placed

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Vestal DM user (more than 6 months)

Exclusion Criteria:

Vestal DM device user (less than 6 months)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Vestal DM device users from any country.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurovalens Ltd., 7 James St. South		Belfast		BT2 8DN	United Kingdom