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Trial record 2 of 4 for:    26898852 [PUBMED-IDS]

Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology (VITAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03148340
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : December 12, 2018
Information provided by (Responsible Party):
Cerebrotech Medical Systems, Inc.

Brief Summary:
The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).

Condition or disease Intervention/treatment
Stroke Stroke, Acute Ischemic Stroke Hemorrhage Clot (Blood); Brain Subarachnoid Hemorrhage Cerebral Infarction Cerebral Hemorrhage Cerebral Stroke Intracerebral Hemorrhage Intracerebral Injury Diagnostic Test: VIPS Monitoring

Detailed Description:
A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.

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Study Type : Observational
Actual Enrollment : 287 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VITAL: Volumetric Integral Phase-shift Spectroscopy (VIPS) for the Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
VIPS monitoring group
The study population will consist of adult patients presenting for evaluation of acute brain pathology,
Diagnostic Test: VIPS Monitoring
Bioimpedance asymmetry
Other Name: CMS

Primary Outcome Measures :
  1. Hemispheric bioimpedance asymmetry detection [ Time Frame: At the time of VIPS monitoring - day 0 ]
    The primary outcome will be the device's ability to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in a population of patients presenting with symptoms consistent with AIS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females, aged 18 years or older, who are undergoing evaluation for acute ischemic stroke

Inclusion Criteria:

  1. Must be at least 18 years of age.
  2. Being evaluated for acute ischemic stroke.
  3. Able to safely wear the study device for up to 2 minutes per reading.
  4. Have NIHSS performed before before study device monitoring.
  5. Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent).

Exclusion Criteria:

  1. Known or suspected traumatic brain injury, either closed or penetrating.
  2. Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography.
  3. Presence of any implanted electro-stimulating devices in the head and neck.
  4. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.)
  5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
  6. Under arrest or otherwise in custody.
  7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.).
  8. Pregnant or nursing.
  9. Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03148340

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United States, Florida
Lyerly Baptist, Inc
Jacksonville, Florida, United States, 32207
United States, New York
University of Buffalo
Buffalo, New York, United States, 14203
The Mount Sinai Hospital
New York, New York, United States, 10029
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Cerebrotech Medical Systems, Inc.


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Responsible Party: Cerebrotech Medical Systems, Inc. Identifier: NCT03148340     History of Changes
Other Study ID Numbers: CH006
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Cerebral Hemorrhage
Cerebral Infarction
Brain Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Brain Infarction
Brain Ischemia
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries