Recording neck artery blood flow signals during carotid artery surgery
Tests whether blood flow signals can be recorded during carotid surgery in adults.
Plain-language title generated from the registry record
Registry title: A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
Key facts
- Where
- Tampa, United StatesSee the site
Where in United States
- Tampa General HospitalTampa, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vibrant Medical Ltd.
- Trial code
- NCT07851389
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
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.
Inclusion: 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: Pregnant patients, as determined by standard-of-care pregnancy testing performed prior to surgery; Known active neck wound, infection, or skin condition at the intended device application site; Emergency or urgent (non-elective) carotid endarterectomy; Planned simultaneous bilateral carotid endarterectomy, which would prevent contralateral recording; 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; Patients who, in the investigator's judgment, are unable or unlikely to comply with the protocol or to provide valid informed consent.