Validation of Neurokeeper's Algorithm on Patients Undergo... | NCT01737736

Studies
Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

NCT01737736

Sponsor

Neurokeeper Technologies

Status

Unknown status

Last Update Posted

Jul 18, 2013Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Stroke

Interventions

Neurokeeper stroke detector

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 27, 2012

First Submission Date that Met QC Criteria

Nov 27, 2012

First Posted Date

Nov 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2013

Last Update Posted Date

Jul 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.

The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study.

This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing cartoid endarterectomy surgery			Device: Neurokeeper stroke detector

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurokeeper stroke detector	Device	Electrophisoloigcal monitoring	Patients undergoing cartoid endarterectomy surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurological detrioration detection	The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.

Secondary Outcomes

Measure	Description	Time Frame
Time from deterioration to detection	The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old.
Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.

Exclusion Criteria:

General anesthesia
Selective carotid artery shunting.
Previous major hemispheric stroke.
Any known major hemispheric lesion.
Significant movement disorder.
Local skull or skin affliction which prevents electrodes application.
Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing Carotid Endarterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shay Bar Haim, Msc	Contact	972506822824		shaybarhaim@neurokeeper.com

Overall Officials

Name	Affiliation	Role
Moshe' Herskovitz, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided