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.
Information provided by (Responsible Party):
Jan Medical, Inc.
First received: February 14, 2012
Last updated: May 9, 2012
Last verified: May 2012
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).
Device: Nautilus NeuroWaveTM System
||Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
||A Non-Randomized, Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM System to Transcranial Doppler as an Aid to Diagnosing Vasospasm
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595802
|University of California San Francisco (UCSF)
|San Francisco, California, United States, 94142-0114 |
Jan Medical, Inc.
||Wade Smith, M.D, PH.D.
||University of California San Francisco (UCSF)
No publications provided
||Jan Medical, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 14, 2012
||May 9, 2012
||United States: Institutional Review Board
Keywords provided by Jan Medical, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Central Nervous System Diseases
Nervous System Diseases