Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

HeadSense Medical

Status: Completed

Conditions: Brain Injuries; Intracranial Hypertension

Treatments: Device: HS-1000

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02772471

HS-016

Details and patient eligibility

About

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.

HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

Full description

A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women subjects, aged 18 years old and over at screening visit
• Subjects with neuropathology that the principal investigator considers including in this study.
• Survival expectancy greater than 72 hours
• Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
• Subject or legal 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
• For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
• 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HS-1000 recording

Experimental group

Description:

ICP monitoring will be done in parallel for both HS-1000 and invasive ICP monitoring. HS-1000 ICP monitoring intervals will last at least 30 minutes, continuously depending on the patient's clinical condition.

Treatment:

Device: HS-1000