Usability Study of CEREBO® - A Novel Non-invasive Intracr... | NCT05340114

Studies
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector

NCT05340114

Sponsor

Bioscan Research Pvt. Ltd.

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Traumatic Brain Injury
Intracranial Hemorrhages

Interventions

CEREBO®

Countries

Not provided

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

ID	Type	Description	Link
CTRI/2022/04/041634	Registry Identifier	Clinical Trials Registry - India (ICMR-NIMS)

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2022Estimated

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

May 31, 2023Estimated

First Submitted Date

Apr 15, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 21, 2022Actual

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

Apr 15, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.

Detailed Description

This prospective study determines the usability of CEREBO® to detect the intracranial hematoma. The operators will receive a training session before the study and will be evaluated at the end of the study through a survey questionnaire for ease of use, ease of learning and satisfaction. Each operator will examine at least 10 subjects with CEREBO®.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects examined by the operations with CEREBO®	Experimental	CEREBO® - A portable non-invasive device to detect intracranial haemorrhage Frequency - The operator will scan at least 10 patients Duration - 40 seconds per subject No adverse effect or contraindications	Device: CEREBO®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CEREBO®	Device	Near-infrared based point-of-care portable intracranial hematoma detector	Subjects examined by the operations with CEREBO®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the summative usability of CEREBO®	Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Operators -

Medical health professionals >18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.

MBBS with Specialisation
MBBS
Nursing Staff
Others

Subjects -

Subjects with suspected traumatic brain injury and GCS > 13
Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects -

Subjects with active bleeding or scalp laceration
Subjects with large extracranial lesions

Accepts Healthy Volunteers

Yes

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bioscan Research	Contact	7948994429	91	info@bioscanresearch.com

Overall Officials

Name	Affiliation	Role
Dr. Jaimin Shah	Civil Hospital India	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D020300	Intracranial Hemorrhages
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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