Vibrant Medical Ltd.
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.
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.…
Inclusion Criteria: * 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. Exclusion Criteria: * 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 s…
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.
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