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An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care

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ClinicalTrials.gov Identifier: NCT02772484
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
State Medical Center, Republic of Armenia
Information provided by (Responsible Party):
HeadSense Medical

Brief Summary:
The HS-1000 device, an investigational intracranial monitoring device, has the potential to safely and quickly diagnose and assess stroke (and potentially other neurologic conditions) with minimal discomfort to patients. HS-1000 has the capability to establish cerebral hemodynamic measurements in suspected stroke within minutes, assist with appropriate management of stroke, and also provide an objective diagnostic tool for clinicians to monitor recovery.

Condition or disease Intervention/treatment Phase
Stroke Device: HS-1000 Not Applicable

Detailed Description:

A prospective study will be conducted on patients with suspected stroke and/or acute neurologic changes treated at the Armenia Republican Medical Center. Male and Female patients over the age of 18 will be eligible for enrollment into the study. Eligible patients or their legally authorized representative (LAR) will be approached for consent to participate in the study. An initial recording session using the HeadSense HS-1000 device will be obtained upon admission to the hospital. During the admission, 2-4 additional recording sessions with the HS-1000 will be completed.

The end-point of the study is to collect up to 30-minute recording with up to 5 sessions of adequate quality for analysis from up to 200 subjects. This data will be correlated with clinical findings obtained during the patient's diagnosis and treatment course. An ease-of-use questionnaire will be administered to the HS-1000 device operator(s) to obtain information regarding the function and workflow aspects of using the HS-1000 in an acute setting to improve assessment, diagnosis and treatment after stroke. The data obtained from the HS-1000 recordings will be analyzed to establish specific waveform patterns correlated with brain physiology after stroke.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: HS-1000 recording
The recording session should be performed in a quiet environment with no disturbance to the patient for a total of up to 60 minutes.
Device: HS-1000



Primary Outcome Measures :
  1. Number of HS recordings that correlate with clinical findings in the diagnosis of stroke [ Time Frame: 60 minutes ]


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
Criteria

Inclusion Criteria:

  • Male and female subjects, > 18 years of age
  • Subjects with suspected stroke and/or acute neurologic changes admitted to Armenia Republican Medical Center
  • Subject or legally authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
  • Subject or legally authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

  • Local ear infection
  • Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
  • Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
  • Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)

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 ClinicalTrials.gov identifier (NCT number): NCT02772484


Locations
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Armenia
State Medical Center, Republic of Armenia
Yerevan, Armenia
Sponsors and Collaborators
HeadSense Medical
State Medical Center, Republic of Armenia
Investigators
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Principal Investigator: Ara Ghazaryan State Medical Center, Republic of Armenia

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Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02772484     History of Changes
Other Study ID Numbers: HS-032
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HeadSense Medical:
noninvasive monitoring