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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02772484 |
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Date of registration:
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12/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
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Scientific title:
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An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02772484 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Armenia
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Contacts
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Name:
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Ara Ghazaryan |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Medical Center, Republic of Armenia |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Device: HS-1000
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Primary Outcome(s)
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Number of HS recordings that correlate with clinical findings in the diagnosis of stroke
[Time Frame: 60 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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