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

NCT01595802 | Completed

• 1 other identifier: DC1B-01
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Vasospasm

Keywords

Cerebral vasospasm

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity as a diagnostic aid in detecting vasospasm in subarachnoid hemorrhage

  Outcome determine Upon completion of study and unmaksing

  12 months

Secondary Outcomes (2)

• Location of vasospasm in the caranium

  12 months

• Incidence of device related adverse events

  12 months

Study Arms (2)

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; Device: Transcranial Doppler (TCD)

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; Device: Transcranial Doppler (TCD)

Interventions

Nautilus NeuroWave DEVICE

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.

Subjects with Vasospasm; Subjects without Vasospasm

Transcranial Doppler (TCD) DEVICE

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.

Subjects with Vasospasm; Subjects without Vasospasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Male or female subjects 18 years of age or older. 2. Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (1)

University of California San Francisco (UCSF)

San Francisco, California, 94142-0114, United States

Location

MeSH Terms

Conditions

Vasospasm, Intracranial

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Wade Smith, M.D, PH.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: May 10, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2015
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)