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

This study has been terminated.
(Insufficient Subject Recruitment)
Sponsor:
Information provided by (Responsible Party):
Jan Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01643525
First received: June 29, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Ischemic Stroke
Device: Nautilus NeuroWaveTM System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A NonRandomized, Multicenter, NonSig Risk Study With a NonInv, Passive PressureWave Method of Diagnosing Cerebral Anomalies to Develop a Diag. Algorithm for Cerebral Isch and to Test Sens./Spec. of This Algorithm in Determining Isch Stroke

Resource links provided by NLM:


Further study details as provided by Jan Medical, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the location to left, right, deep, and/or back of the cranium [ Time Frame: At study completion- approximately 8 months ] [ Designated as safety issue: No ]
  • Incidence of device related adverse events [ Time Frame: At study completion- approximately 8 months ] [ Designated as safety issue: Yes ]
  • Nautilus NeuroWaveTM recording in MRI Normal population (no cerebrovascular disease per MRI) [ Time Frame: At study completion- approximately 8 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nautilus NeuroWave Recording Arm
Nautilus NeuroWaveTM System
Device: Nautilus NeuroWaveTM System
Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.

Detailed Description:

In spite of the fact that approximately 800,000 strokes are diagnosed in the United States each year, many physicians and patients have approached the management of stroke with a sense of futility. However, within the past 2 decades, following the advent of computerized tomography (CT), medical interest has turned toward stroke and effective interventions to treat and prevent it have received attention.

CT and/or magnetic resonance imaging (MRI) are the typical diagnostic tools used in the event of a stroke alert. These studies are done on an emergent or urgent basis, since, to be effective, treatments for ischemic and hemorrhagic stroke must be delivered soon after onset of the illness. In an effort to institute an appropriate therapeutic regime, laboratory and structural diagnostic studies are required to be done as rapidly as possible to determine pathological etiology, size, and location of concern.

The speed at which a diagnosis is made and a treatment plan established often determines patient outcome and any associated complications. This is especially true when evaluating patients for ischemic stroke where there is a narrow 3 hour window of opportunity in which to resolve the clot with IV .before permanent neurological impairment results, and up to 8 additional hours with the use if intra arterial (IA) t-PA or interventional mechanical embolectomy procedures are utilized. Current treatment modalities include pharmacologic thrombolytic drugs utilized to disrupt or dissolve clots located in the distal vasculature or mechanical intervention in larger vessels. Since many patients do not recognize the symptoms of stroke they do not seek medical attention immediately. Significant time is then often lost from the onset of the stroke before seeking medical help / treatment.

Although the current technologies are quite adequate as diagnostic tools for hemorrhagic stroke and for identifying subdural hematomas, and other pooled blood abnormalities which would preclude t-PA therapy, they are largely ineffective at positively identifying stroke during the limited therapeutic window of time. Positive identification of ischemia itself is rarely possible or practical with CT or within the limited therapeutic window. As such the diagnostic determination and associated treatment decisions are based on the unsatisfactory basis of exclusion.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01643525

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205-1911
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Howard County General Hospital
Columbia, Maryland, United States, 21044
Sponsors and Collaborators
Jan Medical, Inc.
Investigators
Principal Investigator: Paul Nyquist Johns Hopkins Medicine
  More Information

No publications provided

Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT01643525     History of Changes
Other Study ID Numbers: NA_00069985
Study First Received: June 29, 2012
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Jan Medical, Inc.:
Ischemic Stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014