NCT02775136

Brief Summary

HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

October 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 30, 2019

Status Verified

December 1, 2016

Enrollment Period

2.7 years

First QC Date

May 13, 2016

Last Update Submit

October 29, 2019

Conditions

Brain InjuriesSubarachnoid HemorrhageVasospasm, IntracranialHydrocephalusBrain Neoplasms

Keywords

brain injuriesneurological monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of recordings that correlate to neuropathology

    Demonstrate the HS-1000 performance and accuracy in brain monitoring

    up to 1 hour

Secondary Outcomes (2)

  • Incidence of adverse events

    48 hours from the end of monitoring with the HS-1000

  • Rate of ear infections/irritations graded by none/mild/moderate and severe

    48 hours from the end of monitoring with the HS-1000

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

Non-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members.

Device: HS-1000 recording

Interventions

HS-1000 recordingDEVICE
HS-1000 recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Subarachnoid hemorrhage (SAH), Fisher Grade 4
  • 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 (4)

Klinikum Darmstadt

Darmstadt, 64283, Germany

RECRUITING

University Hospital Erlangen

Erlangen, Germany

RECRUITING

Universitätsklinik Göttingen

Göttingen, 37075, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, Germany

RECRUITING

MeSH Terms

Conditions

Brain InjuriesSubarachnoid HemorrhageVasospasm, IntracranialHydrocephalusBrain Neoplasms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Oliver Ganslandt, Prof.

    Klinikum Stuttgart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Swanson

CONTACT

thomas@head-sense-med.com

Dana Hromyak

CONTACT

216-526-8534dana@head-sense-med.com

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 13, 2016

First Posted

May 17, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

October 30, 2019

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)