Carotid StenosisNCT07851389
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
An observational study of Carotid Stenosis, run by Vibrant Medical Ltd. at 1 site in United States.
Trial summary
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those signals, in adults undergoing elective carotid endarterectomy (CEA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients (18 years or older) scheduled for elective unilateral carotid endarterectomy at Tampa General Hospital, identified by the treating surgical team from the elective operative schedule and approached during a routine pre-surgical encounter.
Who may be able to join
- Adult patients 18 years of age or older.
- Scheduled to undergo elective unilateral carotid endarterectomy.
- Capable of providing written informed consent pre-operatively.
- No condition precluding placement of an ultrasound transducer at either side of the neck, as determined by the Investigator.
Who cannot join
- Emergency or urgent (non-elective) carotid endarterectomy.
- Planned simultaneous bilateral carotid endarterectomy, which would prevent contralateral recording.
- Known active neck wound, infection, or skin condition at the intended device application site.
- Implanted active device at the neck (e.g., vagal nerve stimulator) that could be affected by external ultrasound.
- Anatomy that prevents transducer contact at either side of the neck, as determined by the Investigator.
- Enrollment in another interventional clinical study that could confound device performance assessment.
- Pregnant patients, as determined by standard-of-care pregnancy testing performed prior to surgery.
- Patients who, in the investigator's judgment, are unable or unlikely to comply with the protocol or to provide valid informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tampa General Hospital
Tampa, Florida, 33606
Charles Briggs, MD
Jean Bismuth, MD
About this study
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those signals, in adults undergoing elective carotid endarterectomy (CEA). During CEA, the surgeon temporarily clamps the internal carotid artery as a routine part of the operation. This produces a brief, controlled and fully reversible stop in blood flow that resembles the blood flow change seen in a large-vessel ischemic stroke.
The main questions it aims to answer are:
Read more
- Can usable, continuous blood flow signals be recorded from both sides of the neck before and during carotid clamping?
- Do the recorded signals show consistent, repeatable changes that are time-locked to carotid clamping and release across patients?
Participants will have their scheduled surgery as usual. During surgery, two legally marketed, FDA-cleared diagnostic ultrasound systems will record blood flow from the common carotid artery on each side of the neck, before clamping, during clamping and after the clamp is released, for about 20 to 30 minutes in total. The recordings are analyzed later and are not seen or used by the surgical team. No part of the surgery or anesthesia care is changed, and there are no study visits after surgery.
Read the detailed description
Background
In-hospital stroke is often recognized late, because patients may be sedated, anesthetized or otherwise unable to report symptoms, and there is currently no cleared device that continuously monitors carotid blood flow to flag a sudden change. Vibrant Medical is developing a wearable, non-invasive ultrasound sensor for this purpose. The element that is first-in-human in this study is Vibrant Medical's analysis method (wave-intensity and bilateral-asymmetry processing of carotid Doppler signals), which has previously been applied only to benchtop flow-phantom and in-vivo ovine data.
Carotid endarterectomy provides a controlled clinical model for this first human evaluation: the internal carotid artery clamp is applied and released by the surgeon as part of standard technique, producing a time-stamped, reversible reduction in carotid flow with no additional risk to the patient.
Study design
This is a prospective, single-center, single-arm, observational feasibility study at Tampa General Hospital / University of South Florida. Signals are acquired with two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication.
Recording phases
- Baseline (pre-clamp): 1 to 2 minutes of continuous recording after stable signal acquisition and before any clamping.
- Internal carotid artery clamping: recording from just before clamp application through 1 to 2 minutes of clamping.
- Planned non-recording interval: both transducers are removed during arteriotomy, plaque removal and closure.
- Reperfusion: transducers are re-applied after closure, if this does not delay the surgical team, and recording continues from before clamp release through 1 to 2 minutes of restored flow.
No surgical step, including clamp timing, is delayed, modified or made contingent on the recordings. If a stable signal is not available when the surgeon is ready, the case proceeds unchanged and the phase is documented as missed.
Data collection and analysis
A study coordinator records time stamps of transducer placement, clamp application and release, and each recording phase on a case report form. Blood pressure, heart rate and the standard-of-care neuromonitoring data for the case are extracted from the anesthesia record and time-stamped to surgical events. Demographic and clinical variables (such as age, sex, BMI, surgical side and ASA class) are abstracted from the medical record. Recordings are exported and analyzed offline by Vibrant Medical research software labeled For Research Use Only; no output is available to the clinical team. Results are summarized descriptively; this feasibility study is not powered for hypothesis testing.
- Conditions
- Carotid Stenosis
- Being tested
- Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)
- Keywords
- Carotid Endarterectomy, Stroke Detection, In-Hospital Stroke, Carotid Doppler Ultrasound, Wave Intensity Analysis, Continuous Hemodynamic Monitoring, First-in-Human
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)Device
External, non-invasive recording of common carotid artery flow on both sides of the neck using two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication: Telemed ArtUs EXT-2H with L12-5N40-A4 transducer (510(k) K211248) and Telemed SmartUs EXT-1M with L15-7L40H-5 transducer (510(k) K163121). Recordings are analyzed offline with Vibrant Medical research software (For Research Use Only). No output is shown to the surgical team and no clinical decision is based on the recordings.
| Study group | Role | What they receive |
|---|---|---|
| Elective Carotid Endarterectomy Patients | Adults undergoing elective unilateral carotid endarterectomy at Tampa General Hospital. Continuous bilateral common carotid Doppler signals are recorded intra-operatively at pre-clamp baseline, during internal carotid artery clamping, and at reperfusion, for approximately 20 to 30 minutes in total. Surgical and anesthesia care are not modified, and the recordings are not available to the clinical team. Receives: Device: Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Baseline and Internal Carotid Artery Clamping
A subject is counted as a success when usable, continuous bilateral common carotid flow signal is acquired for the full duration of Phase 1 (pre-clamp baseline) and Phase 2 (internal carotid artery clamping), adjudicated against signal-quality criteria fixed before the first subject is enrolled. Subjects in whom acquisition fails are retained in the denominator. Reported as the percentage of enrolled subjects with an exact (Clopper-Pearson) 95% confidence interval, against a descriptive benchmark of at least 80%. This is not a hypothesis test. Phase 3 (reperfusion) is not part of this measure.
Measured: Intra-operative, from pre-clamp baseline through internal carotid artery clamping (single surgical encounter)
Secondary outcomes (2)
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Reperfusion
Usable, continuous bilateral signal acquired for Phase 3, from before internal carotid artery clamp release through 1 to 2 minutes of restored flow. Reported descriptively and separately from the primary outcome, because both transducers are removed during the endarterectomy and re-application depends on not delaying the surgical team.
Measured: Intra-operative, from before clamp release through 1 to 2 minutes of reperfusion
Carotid Flow Signal Characteristics Time-Locked to Internal Carotid Artery Clamp Application and Release
Signal characteristics, including flow velocity, wave-intensity and bilateral-asymmetry measures, described per subject relative to the documented clamp application and release time stamps, and summarized descriptively. All enrolled subjects with any recorded data are included; no imputation is performed and missing phases are reported as missing.
Measured: Intra-operative, from pre-clamp baseline through reperfusion (single surgical encounter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vibrant Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Briggs, MD, Principal investigator, Tampa General Hospital / University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851389
- Sponsor's protocol ID
- VM-FIH-CEA-01
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data are coded, held under the data provisions of the clinical trial agreement, and are not planned for sharing. Aggregate study results will be made publicly available through publication or conference presentation.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
- ClinicalTrials.gov ID
- NCT07851389
- Acronym / sponsor ID
- VM-FIH-CEA-01
- Conditions
- Carotid Stenosis
- Keywords
- Carotid Endarterectomy, Stroke Detection, In-Hospital Stroke, Carotid Doppler Ultrasound, Wave Intensity Analysis, Continuous Hemodynamic Monitoring, First-in-Human
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vibrant Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Oct 2026 (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.
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those signals, in adults undergoing elective carotid endarterectomy (CEA). During CEA, the surgeon temporarily clamps the internal carotid artery as a routine part of the operation. This produces a brief, controlled and fully reversible stop in blood flow that resembles the blood flow change seen in a large-vessel ischemic stroke.
The main questions it aims to answer are:
- Can usable, continuous blood flow signals be recorded from both sides of the neck before and during carotid clamping?
- Do the recorded signals show consistent, repeatable changes that are time-locked to carotid clamping and release across patients?
Participants will have their scheduled surgery as usual. During surgery, two legally marketed, FDA-cleared diagnostic ultrasound systems will record blood flow from the common carotid artery on each side of the neck, before clamping, during clamping and after the clamp is released, for about 20 to 30 minutes in total. The recordings are analyzed later and are not seen or used by the surgical team. No part of the surgery or anesthesia care is changed, and there are no study visits after surgery.
Detailed description
Background
In-hospital stroke is often recognized late, because patients may be sedated, anesthetized or otherwise unable to report symptoms, and there is currently no cleared device that continuously monitors carotid blood flow to flag a sudden change. Vibrant Medical is developing a wearable, non-invasive ultrasound sensor for this purpose. The element that is first-in-human in this study is Vibrant Medical's analysis method (wave-intensity and bilateral-asymmetry processing of carotid Doppler signals), which has previously been applied only to benchtop flow-phantom and in-vivo ovine data.
Carotid endarterectomy provides a controlled clinical model for this first human evaluation: the internal carotid artery clamp is applied and released by the surgeon as part of standard technique, producing a time-stamped, reversible reduction in carotid flow with no additional risk to the patient.
Study design
This is a prospective, single-center, single-arm, observational feasibility study at Tampa General Hospital / University of South Florida. Signals are acquired with two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication.
Recording phases
- Baseline (pre-clamp): 1 to 2 minutes of continuous recording after stable signal acquisition and before any clamping.
- Internal carotid artery clamping: recording from just before clamp application through 1 to 2 minutes of clamping.
- Planned non-recording interval: both transducers are removed during arteriotomy, plaque removal and closure.
- Reperfusion: transducers are re-applied after closure, if this does not delay the surgical team, and recording continues from before clamp release through 1 to 2 minutes of restored flow.
No surgical step, including clamp timing, is delayed, modified or made contingent on the recordings. If a stable signal is not available when the surgeon is ready, the case proceeds unchanged and the phase is documented as missed.
Data collection and analysis
A study coordinator records time stamps of transducer placement, clamp application and release, and each recording phase on a case report form. Blood pressure, heart rate and the standard-of-care neuromonitoring data for the case are extracted from the anesthesia record and time-stamped to surgical events. Demographic and clinical variables (such as age, sex, BMI, surgical side and ASA class) are abstracted from the medical record. Recordings are exported and analyzed offline by Vibrant Medical research software labeled For Research Use Only; no output is available to the clinical team. Results are summarized descriptively; this feasibility study is not powered for hypothesis testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Carotid Endarterectomy Patients | – | Device: Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)Adults undergoing elective unilateral carotid endarterectomy at Tampa General Hospital. Continuous bilateral common carotid Doppler signals are recorded intra-operatively at pre-clamp baseline, during internal carotid artery clamping, and at reperfusion, for approximately 20 to 30 minutes in total. Surgical and anesthesia care are not modified, and the recordings are not available to the clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years or older) scheduled for elective unilateral carotid endarterectomy at Tampa General Hospital, identified by the treating surgical team from the elective operative schedule and approached during a routine pre-surgical encounter.
Key inclusion criteria (4 listed)
- Adult patients 18 years of age or older.
- Scheduled to undergo elective unilateral carotid endarterectomy.
- Capable of providing written informed consent pre-operatively.
- No condition precluding placement of an ultrasound transducer at either side of the neck, as determined by the Investigator.
Key exclusion criteria (8 listed)
- Emergency or urgent (non-elective) carotid endarterectomy.
- Planned simultaneous bilateral carotid endarterectomy, which would prevent contralateral recording.
- Known active neck wound, infection, or skin condition at the intended device application site.
- Implanted active device at the neck (e.g., vagal nerve stimulator) that could be affected by external ultrasound.
- Anatomy that prevents transducer contact at either side of the neck, as determined by the Investigator.
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 |
|---|---|---|
| Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)External, non-invasive recording of common carotid artery flow on both sides of the neck using two legally marketed, FDA-cleared Class II diagnostic ultrasound systems, one per side, each used within its cleared Peripheral Vessel indication: Telemed ArtUs EXT-2H with L12-5N40-A4 transducer (510(k) K211248) and Telemed SmartUs EXT-1M with L15-7L40H-5 transducer (510(k) K163121). Recordings are analyzed offline with Vibrant Medical research software (For Research Use Only). No output is shown to the surgical team and no clinical decision is based on the recordings. | Device | Elective Carotid Endarterectomy Patients |
Primary outcome
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Baseline and Internal Carotid Artery Clamping
Time frame: Intra-operative, from pre-clamp baseline through internal carotid artery clamping (single surgical encounter)
A subject is counted as a success when usable, continuous bilateral common carotid flow signal is acquired for the full duration of Phase 1 (pre-clamp baseline) and Phase 2 (internal carotid artery clamping), adjudicated against signal-quality criteria fixed before the first subject is enrolled. Subjects in whom acquisition fails are retained in the denominator. Reported as the percentage of enrolled subjects with an exact (Clopper-Pearson) 95% confidence interval, against a descriptive benchmark of at least 80%. This is not a hypothesis test. Phase 3 (reperfusion) is not part of this measure.
2 secondary outcomes
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Reperfusion
Time frame: Intra-operative, from before clamp release through 1 to 2 minutes of reperfusion
Carotid Flow Signal Characteristics Time-Locked to Internal Carotid Artery Clamp Application and Release
Time frame: Intra-operative, from pre-clamp baseline through reperfusion (single surgical encounter)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are coded, held under the data provisions of the clinical trial agreement, and are not planned for sharing. Aggregate study results will be made publicly available through publication or conference presentation.
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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.
Charles Briggs, MD principal investigator
Tampa General Hospital / University of South Florida
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 Carotid Stenosis, run by Vibrant Medical Ltd. 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avennette Pinto (813-505-4787, apinto3@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Successful Bilateral Carotid Signal Acquisition During Baseline and Internal Carotid Artery Clamping (time frame: Intra-operative, from pre-clamp baseline through internal carotid artery clamping (single surgical encounter)). 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 1 Oct 2026.