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Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Neurokeeper Technologies.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737736
First Posted: November 29, 2012
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurokeeper Technologies
  Purpose

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.


Condition Intervention
Stroke Device: Neurokeeper stroke detector

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Neurokeeper Technologies:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Study Start Date: June 2013
Groups/Cohorts Assigned Interventions
Patients undergoing cartoid endarterectomy surgery Device: Neurokeeper stroke detector
Electrophisoloigcal monitoring

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Carotid Endarterectomy
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737736


Contacts
Contact: Shay Bar Haim, Msc 972506822824 shaybarhaim@neurokeeper.com

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Moshe Herskovitz, MD    97248542605    m_herskovitz@rambam.health.gov.il   
Sponsors and Collaborators
Neurokeeper Technologies
Investigators
Principal Investigator: Moshe` Herskovitz, MD Rambam Health Care Campus
  More Information

Responsible Party: Neurokeeper Technologies
ClinicalTrials.gov Identifier: NCT01737736     History of Changes
Other Study ID Numbers: NK-004
First Submitted: November 27, 2012
First Posted: November 29, 2012
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Neurokeeper Technologies:
Stroke