Stroke, AcuteVIGORNCT03767842
Volumetric Impedance to Guide Stroke Response
An observational study of Stroke, Acute, run by Cerebrotech Medical Systems, Inc. at 1 site in United States.
Trial summary
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Visor System
- Type of treatment
- Medical device
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 31 Mar 2019
- 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
- Adult, Older adult
Study population: Patients presenting for evaluation of acute stroke
Who may be able to join
- Being evaluated as a suspected stroke
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Buffalo Neurosurgery
Buffalo, New York, 14203
Adrian Parker, 978-409-0451, aparker@vastrax.com
About this study
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry
- Conditions
- Stroke, Acute
- Being tested
- Visor System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visor SystemDevice
Subjects are monitored one time with the Visor System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemispheric bioimpedance asymmetry sensitivity and specificity
Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke
Measured: At the time of device monitoring - day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start18 Jul 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerebrotech Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher P Kellner, MD, Principal investigator, Sinai Health SystemAndrei V Alexandrov, MD, Principal investigator, University of TennesseeRaul G Nogueira, MD, Principal investigator, Emory University School of Medicine, Grady Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767842
- Sponsor's protocol ID
- CH007
- Acronym
- VIGOR
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-2017-013690. Epub 2018 Mar 6.
PubMed 29511114
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Impedance to Guide Stroke Response
- ClinicalTrials.gov ID
- NCT03767842
- Acronym / sponsor ID
- VIGOR / CH007
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Cerebrotech Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 7 Dec 2018 (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.
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for evaluation of acute stroke
Key inclusion criteria (1 listed)
- Being evaluated as a suspected stroke
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Visor SystemSubjects are monitored one time with the Visor System. | Device | – |
Primary outcome
Hemispheric bioimpedance asymmetry sensitivity and specificity
Time frame: At the time of device monitoring - day 0
Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Results publication: PubMed 29511114Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-2017-013690. Epub 2018 Mar 6.
- Individual participant dataSharing planned: No
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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.
Christopher P Kellner, MD principal investigator
Sinai Health System
Andrei V Alexandrov, MD principal investigator
University of Tennessee
Raul G Nogueira, MD principal investigator
Emory University School of Medicine, Grady Memorial Hospital
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 Stroke, Acute, run by Cerebrotech Medical Systems, Inc. at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 7 Dec 2018. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Parker (978-409-0451, aparker@vastrax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemispheric bioimpedance asymmetry sensitivity and specificity (time frame: At the time of device monitoring - day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767842, which also lists 1 linked publication.
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 7 Dec 2018.