NCT03981757

Brief Summary

Study of Regional cerebral Oxygenation and Brain Blood Volume changes during Carotid Endarterectomy using the NeurOS system

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
3.6 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

June 6, 2019

Last Update Submit

February 13, 2024

Conditions

Carotid Disease

Keywords

carotid surgerycerebral oxygenationbrain blood volume

Outcome Measures

Primary Outcomes (1)

  • Regional Cerebral Oxygenation

    Regional Cerebral Oxygenation during Carotid Endarterectomy

    From the beginning of surgery until the end of surgery for each patient enrolled

Secondary Outcomes (1)

  • NeurOS Brain Blood Volume

    From the beginning of surgery until the end of surgery for each patient enrolled

Study Arms (1)

NeurOS Group

EXPERIMENTAL

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.

Device: NeurOS

Interventions

NeurOSDEVICE

NeurOS system pads will be placed on patients' head for monitoring.

NeurOS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having carotid endarterectomy at Jewish Hospital, Louisville, KY Agree to study protocol No allergy to either INOVS or NeurOS system pads

You may not qualify if:

  • Refusal to participate Emergency surgery Allergy to either INOVS or NeurOS system pads

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Jiapeng Huang, MD, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients will have NeurOS pads placed on their foreheads. Continuous monitoring of arterial blood pressure, cerebral oxygenation and brain blood volume index for the whole length of surgery will be recorded and saved in a USB drive for retrieval and analysis. Key point data include: Baseline, Anesthesia Induction, Incision, Carotid Clamping, Clamp Release and Skin Closure. These key points data will be extracted for analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 11, 2019

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)