Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage
Sponsor
Neurovalens Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04783883
Collaborator
R D Gardi Medical College, Ujjain (Other)
25
1
4.6
5.4
Study Details
Study Description
Brief Summary
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
25 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage
Actual Study Start Date
:
Mar 4, 2021
Actual Primary Completion Date
:
Jul 5, 2021
Actual Study Completion Date
:
Jul 23, 2021
Outcome Measures
Primary Outcome Measures
- Assessment of hearing function as reported by formal audiometry testing [Baseline]
Formal audiometry testing to be conducted using the AMTAS Flex Device
Secondary Outcome Measures
- Frequency of device related adverse events [Baseline]
- Inspection of the skin behind the ears (mastoid area) [Baseline]
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
- Otoscope examination of the inside of both ear canals and tympanic membranes [Baseline]
Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Vestal DM user (more than 6 months)
Exclusion Criteria:
- Vestal DM device user (less than 6 months)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neurovalens Ltd., 7 James St. South | Belfast | United Kingdom | BT2 8DN |
Sponsors and Collaborators
- Neurovalens Ltd.
- R D Gardi Medical College, Ujjain
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Neurovalens Ltd.
ClinicalTrials.gov Identifier:
NCT04783883
Other Study ID Numbers:
- RWDMES01
First Posted:
Mar 5, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Neurovalens Ltd.