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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772471
• Other study ID #: HS-016
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: May 12, 2016
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: HeadSense Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Brain Injuries
• Intracranial Hypertension

Intervention

Device:
• HS-1000

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
HeadSense Medical	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Levinsky A, Papyan S, Weinberg G, Stadheim T, Eide PK. Non-invasive estimation of static and pulsatile intracranial pressure from transcranial acoustic signals. Med Eng Phys. 2016 May;38(5):477-84. doi: 10.1016/j.medengphy.2016.02.009. Epub 2016 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ICP values obtained by the HS device that correlate to ICP using current standards		30 minutes	No