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NeurOS Monitoring for Carotid Disease Surgery (COBBV-CE Trial)

N/A
Waitlist Available
Led By Jiapeng Huang, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the beginning of surgery until the end of surgery for each patient enrolled
Awards & highlights

COBBV-CE Trial Summary

This trial looked at how well a new system, NeurOS, could measure changes in oxygen and blood levels in the brain during surgery to remove blockages in the carotid artery.

Who is the study for?
This trial is for individuals undergoing carotid endarterectomy at Jewish Hospital in Louisville, KY. Participants must agree to the study protocol and not have allergies to INOVS or NeurOS system pads. It's not open to those who refuse participation, have relevant allergies, or require emergency surgery.Check my eligibility
What is being tested?
The trial is studying how a device called NeurOS affects brain oxygen levels and blood volume during carotid artery surgery. The goal is to understand if this monitoring can improve patient outcomes.See study design
What are the potential side effects?
Since the NeurOS system is used for monitoring during surgery rather than treatment, it may cause minimal side effects related to pad placement on the skin such as discomfort or potential skin irritation.

COBBV-CE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the beginning of surgery until the end of surgery for each patient enrolled
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the beginning of surgery until the end of surgery for each patient enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Regional Cerebral Oxygenation
Secondary outcome measures
NeurOS Brain Blood Volume

COBBV-CE Trial Design

1Treatment groups
Experimental Treatment
Group I: NeurOS GroupExperimental Treatment1 Intervention
Apply the single use NeurOS cerebral oximetry sensor adhesive onto patients' head who are going to have CEA surgery in the operating room before anesthesia induction.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,685 Total Patients Enrolled
Jiapeng Huang, MD, PhDPrincipal Investigator - University of Louisville
University of Louisville
4 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

NeurOS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03981757 — N/A
Carotid Disease Research Study Groups: NeurOS Group
Carotid Disease Clinical Trial 2023: NeurOS Highlights & Side Effects. Trial Name: NCT03981757 — N/A
NeurOS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03981757 — N/A
~0 spots leftby May 2025
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