NCT02773888

Brief Summary

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

May 12, 2016

Last Update Submit

February 23, 2017

Conditions

Intracranial HypertensionBrain InjuriesStrokeHydrocephalusBrain Neoplasms

Keywords

intracranial pressurenoninvasive monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of ICP values obtained by the HS device that correlate to ICP using current standards

    30 minutes

Secondary Outcomes (1)

  • Incidence of adverse events during and after recording sessions

    96 hours

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.

Device: HS-1000

Interventions

HS-1000DEVICE
HS-1000 recording

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, aged 14 years old and over at screening visit
  • Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology
  • Survival expectancy greater than 48 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

You may not qualify if:

  • Subject with ear disease, ear trauma
  • Subject with a punctured or discontinuous dura layer (must be intact)
  • Subject with cerebral fluid (CSF) leakage
  • 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

Study Sites (5)

Kuki General Hospital

Saitama, Japan

Location

National Defense Medical College Hospital

Saitama, Japan

Location

Juntendo University Shizuoka Hospital

Shizuoka, Japan

Location

Nippon Medical School

Tokyo, Japan

Location

Tokyo Jikei University Kashiwa Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Intracranial HypertensionBrain InjuriesStrokeHydrocephalusBrain Neoplasms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Katsuji Shima

    National Defense Medical College

    PRINCIPAL INVESTIGATOR

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 16, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 27, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(5)