NCT07851389Not yet recruiting
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Vibrant Medical Ltd.
- Diseases
- Stroke
- NCT number
- NCT07851389
What you commit to
- Study type: Observational
- Planned participants: 10
- From Oct 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant patients, as determined by standard-of-care pregnancy testing performed prior to surgery.
Other illness
- Known active neck wound, infection, or skin condition at the intended device application site.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.