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

NCT01643525 | Terminated Results

• 1 other identifier: NA_00069985
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device Related Adverse Events

  Count the number of participants with device related adverse events

  2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)

Study Arms (2)

Subjects with Stroke Symptoms

Suspected stroke subjects that present to hospital with stroke symptoms and are evaluated for stroke

Device: Nautilus NeuroWaveTM System

Normal Cohort

Subjects that are not being evaluated for stroke and are confirmed to have no cerebrovascular disease

Device: Nautilus NeuroWaveTM System

Interventions

Nautilus NeuroWaveTM System DEVICE

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

Normal Cohort; Subjects with Stroke Symptoms

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with stroke symptoms that are being evaluated for stroke or healthy subjects that have no cerebrovascular disease and are not being evaluated for symptoms of stroke.

You may qualify if:

• Symptoms consistent with stroke with known onset \< 12 hours prior to enrollment and planned recording with the Nautilus NeuroWave System
• Suspected pathology of following vessels: internal carotid artery, ACA, MCA, PCA, basilar or other anterior or posterior cerebral vessels or normal anatomy
• Subject is planned to undergo standard stroke triage imaging protocol
• Able to understand and provide signed informed consent, or have a Legally Authorized Representative willing to provide informed consent on subject's behalf

You may not qualify if:

• Known to meet hospital criteria for brain death
• Not a candidate for CT, MRI
• unknown time of stroke symptom onset.
• Psychologically unstable and not able to cooperate
• Not suitable for participation in this study in the opinion of the Investigator

Sponsors & Collaborators

• Jan Medical, Inc.: lead

Study Sites (3)

Johns Hopkins Hospital

Baltimore, Maryland, 21205-1911, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Paul Nyquist
• Organization: Johns Hopkins University

pnyquis1@jhmi.edu

Study Officials

• Paul Nyquist

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 18, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 8, 2024
• Results First Posted: June 19, 2015

Record last verified: 2024-07

Locations

US (3)