Safety IssuesNCT04783883
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage
An observational study of Safety Issues, run by Neurovalens Ltd. at 1 site in United Kingdom.
Trial summary
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues
- What is being tested?
- Vestal DM
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2021to 23 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vestal DM device users from any country.
Who may be able to join
- Vestal DM user (more than 6 months)
Who cannot join
- Vestal DM device user (less than 6 months)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neurovalens Ltd., 7 James St. South
Belfast, BT2 8DN
About this study
Official title: Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Vestal DM
- Keywords
- Neuromodulation, Safety, Vestibular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestal DMDevice
Battery powered non-invasive neurostimulation device (1.5mA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hearing function as reported by formal audiometry testing
Formal audiometry testing to be conducted using the AMTAS Flex Device
Measured: Baseline
Secondary outcomes (3)
Frequency of device related adverse events
Measured: 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
Measured: Baseline
Otoscope examination of the inside of both ear canals and tympanic membranes
Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start4 Mar 2021
- Primary completion5 Jul 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R D Gardi Medical College, Ujjain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783883
- Sponsor's protocol ID
- RWDMES01
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage
- ClinicalTrials.gov ID
- NCT04783883
- Acronym / sponsor ID
- RWDMES01
- Conditions
- Safety Issues
- Keywords
- Neuromodulation, Safety, Vestibular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R D Gardi Medical College, Ujjain
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vestal DM device users from any country.
Key inclusion criteria (1 listed)
- Vestal DM user (more than 6 months)
Key exclusion criteria (1 listed)
- Vestal DM device user (less than 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestal DMBattery powered non-invasive neurostimulation device (1.5mA) | Device | – |
Primary outcome
Assessment of hearing function as reported by formal audiometry testing
Time frame: Baseline
Formal audiometry testing to be conducted using the AMTAS Flex Device
3 secondary outcomes
Frequency of device related adverse events
Time frame: Baseline
Inspection of the skin behind the ears (mastoid area)
Time frame: Baseline
Otoscope examination of the inside of both ear canals and tympanic membranes
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues, run by Neurovalens Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hearing function as reported by formal audiometry testing (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.