A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies

NCT07851389 | Not Yet Recruiting FDA Device

• 1 other identifier: VM-FIH-CEA-01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Carotid Stenosis

Keywords

Carotid Endarterectomy; Stroke Detection; In-Hospital Stroke; Carotid Doppler Ultrasound; Wave Intensity Analysis; Continuous Hemodynamic Monitoring; First-in-Human

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Intra-operative, from pre-clamp baseline through reperfusion (single surgical encounter)

Study Arms (1)

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.

Device: Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)

Interventions

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.

Elective Carotid Endarterectomy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vibrant Medical Ltd.: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles Briggs, MD

  Tampa General Hospital / University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avennette Pinto

CONTACT

813-505-4787; apinto3@usf.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)