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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the beginning of surgery until the end of surgery for each patient enrolled

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,984 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for volunteers to join this research endeavor?

"Confirming the information on clinicaltrials.gov, this investigation is still open to participants; it was initially posted on January 1st 2023 and its details were last updated in May 7th 2022."

Answered by AI

What is the capacity of participants for this experimental process?

"Affirmative. Clinicaltrials.gov documents verify that this research is recruiting, having been posted on January 1st 2023 and updated lastly on May 7th 2022. The medical trial requires 100 participants from a single location to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System

Jiapeng Huang 2023. "Study of Regional Cerebral Oxygenation and Brain Blood Volume Changes During Carotid Endarterectomy Using the NeurOS System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03981757.