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

Conditions

• Carotid Stenosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Oct 1, 2026

Start date

Oct 31, 2026

Status verified

Sep 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

10 participants (estimated)

Arms

• Arm: 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.

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) ]

Central Contacts

• Avennette Pinto
  813-505-4787
  [email protected]

Locations (1)

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