An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Apr 2016
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 29, 2016
December 1, 2016
8 months
May 12, 2016
December 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of HS recordings that correlate with clinical findings in the diagnosis of stroke
60 minutes
Study Arms (1)
HS-1000 recording
EXPERIMENTALThe recording session should be performed in a quiet environment with no disturbance to the patient for a total of up to 60 minutes.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HeadSense Medicallead
- State Medical Center, Republic of Armeniacollaborator
Study Sites (1)
State Medical Center, Republic of Armenia
Yerevan, Armenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ara Ghazaryan
State Medical Center, Republic of Armenia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 13, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 29, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share