A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
NCT: NCT07851389 · NOT_YET_RECRUITING
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.
Frequently Asked Questions
What is A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies?
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies is a clinical trial registered under NCT07851389. Current status: NOT_YET_RECRUITING.
What is the status of NCT07851389?
The current status of NCT07851389 (A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies) is: NOT_YET_RECRUITING.
When did A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies start?
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies started on 2026-10.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.