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Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke

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.
ClinicalTrials.gov Identifier: NCT01643525
Recruitment Status : Terminated (Insufficient Subject Recruitment)
First Posted : July 18, 2012
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Ischemic Stroke
Intervention: Device: Nautilus NeuroWaveTM System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nautilus NeuroWave Recording Arm

Nautilus NeuroWaveTM System

Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.


Participant Flow:   Overall Study
    Nautilus NeuroWave Recording Arm
STARTED   29 
COMPLETED   29 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nautilus NeuroWave Recording Arm

Nautilus NeuroWaveTM System

Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.


Baseline Measures
   Nautilus NeuroWave Recording Arm 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (16.2) 
Gender, Customized 
[Units: Participants]
 
Females Known   16 
Males Known   7 
Region of Enrollment 
[Units: Participants]
 
United States   29 


  Outcome Measures

1.  Primary:   Sensitivity, Specificity and Predictive Values of the Jan Medical DC1 System in Detecting Ischemia Within 12 Hours of Known Stroke Onset in Comparison to Follow up CT and MRI.   [ Time Frame: At study completion- approximately 8 months ]

2.  Secondary:   Determine the Location to Left, Right, Deep, and/or Back of the Cranium   [ Time Frame: At study completion- approximately 8 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Incidence of Device Related Adverse Events   [ Time Frame: At study completion- approximately 8 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)   [ Time Frame: At study completion- approximately 8 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Paul Nyquist
Organization: Johns Hopkins University
e-mail: pnyquis1@jhmi.edu



Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT01643525     History of Changes
Other Study ID Numbers: NA_00069985
First Submitted: June 29, 2012
First Posted: July 18, 2012
Results First Submitted: June 2, 2015
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015