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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01595802
First received: February 14, 2012
Last updated: February 23, 2016
Last verified: February 2016
  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 NeuroWave
Device: Transcranial Doppler (TCD)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 and specificity 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


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 ]

Enrollment: 72
Study Start Date: January 2012
Study Completion Date: July 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects without Vasospasm
Transcranial Doppler (TCD) will be used to evaluate if subject has a vasospasm. Intervention with Nautilus NeuroWave recording to obtain baseline status.
Device: Nautilus NeuroWave

The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made.

In this intervention, patients are recorded using the Nautilus Neurowave device.

Device: Transcranial Doppler (TCD)
Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.
Experimental: Subjects with Vasospasm

Transcranial Doppler (TCD) will be used to evaluate if subject has a vasospasm. If confirmed by TCD, the degree of vasospasm will also be evaluated and classified as mild, moderate and severe Vasospasm.

Intervention with Nautilus NeuroWave recording to obtain recordings with mild, moderate and severe Vasospasm.

Device: Nautilus NeuroWave

The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made.

In this intervention, patients are recorded using the Nautilus Neurowave device.

Device: Transcranial Doppler (TCD)
Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

Locations
United States, California
University of California San Francisco (UCSF)
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

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: February 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 July 28, 2016