Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM to Transcranial Doppler as an Aid to Diagnosing Vasospasm

This study is currently recruiting participants.

Verified May 2012 by Jan Medical, Inc.

Sponsor:

Information provided by (Responsible Party):

Jan Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01595802

First received: February 14, 2012

Last updated: May 9, 2012

Last verified: May 2012

History of Changes

Purpose

The purpose of the study is to determine the sensitivity, specificity and predictive values of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison to Trans Cranial Doppler(TCD).

Condition	Intervention
Cerebral Vasospasm	Device: Nautilus NeuroWaveTM System

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	A Non-Randomized, Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM System to Transcranial Doppler as an Aid to Diagnosing Vasospasm

Further study details as provided by Jan Medical, Inc.:

Primary Outcome Measures:

Sensitivity as a diagnostic aid in detecting vasospasm in subarachnoid hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Outcome determine Upon completion of study and unmaksing
Specificity as a diagnostic aid in detection of vasospasm in subarachnoid hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Outcome determined upon completion of study and unmasking

Secondary Outcome Measures:

Location of vasospasm in the caranium [ Time Frame: 12 months ] [ Designated as safety issue: No ]
outcome determine upon completion of study and unmasking
Incidence of device related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2012
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

A noninvasive device to detect cerebral vasospasm utilizing headset and sensors

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects 18 years of age or older.
Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.
Signed informed consent from the patient or the patient's Legally Authorized Representative

Exclusion Criteria:

Unstable medical illness such that recordings might interfere with medical care.
Presence of head bandages or brain monitors that might physically interfere with the tested recording device.
Current hemicraniectomy.
Subjects who are not candidates for Transcranial Doppler assessment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595802

Contacts

Contact: Wade Smith, M.D, PH.D.

(415) 353-1489

smithw@neurology.ucsf.edu

Locations

United States, California
University of California San Francisco (UCSF)	Recruiting
San Francisco, California, United States, 94142-0114

Sponsors and Collaborators

Jan Medical, Inc.

Investigators

Principal Investigator:

Wade Smith, M.D, PH.D.

University of California San Francisco (UCSF)

More Information

No publications provided

Responsible Party:	Jan Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01595802 History of Changes
Other Study ID Numbers:	DC1B-01
Study First Received:	February 14, 2012
Last Updated:	May 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Jan Medical, Inc.:

Cerebral vasospasm

Additional relevant MeSH terms:

Vasospasm, Intracranial
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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