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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772484
• Other study ID #: HS-032
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: December 28, 2016
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: HeadSense Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Armenia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• HS-1000

Locations

Country	Name	City	State
Armenia	State Medical Center, Republic of Armenia	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
HeadSense Medical	State Medical Center, Republic of Armenia

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HS recordings that correlate with clinical findings in the diagnosis of stroke		60 minutes	No