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A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
Sponsor: Vibrant Medical Ltd.
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10
Start Date
2026-10
Completion Date
2027-03
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Tampa General Hospital
Tampa, Florida, United States