Development and Evaluation of the ICP Waveform Tracing Ca... | NCT02772471

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

NCT02772471

Sponsor

HeadSense Medical

Status

Completed

Last Update Posted

May 13, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Brain Injuries
Intracranial Hypertension

Interventions

HS-1000

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 12, 2016

First Posted Date

May 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2016

Last Update Posted Date

May 13, 2016Estimated

Name	Class
Oslo University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HS-1000 recording	Experimental	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.	Device: HS-1000

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HS-1000	Device		HS-1000 recording

Measure	Description	Time Frame
Number of ICP values obtained by the HS device that correlate to ICP using current standards		30 minutes

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Per Kristian Eide, MD, PhD	Oslo University Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26997563	Result	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

ID	Term
D001930	Brain Injuries
D019586	Intracranial Hypertension