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

Primary Purpose

Traumatic Brain Injury, Intracranial Hemorrhages

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CEREBO®

About this trial

This is an interventional device feasibility trial for Traumatic Brain Injury focused on measuring Ease of Use, Ease of Learning, Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects examined by the operations with CEREBO®

Arm Description

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

Outcomes

Primary Outcome Measures

To evaluate the summative usability of CEREBO®

Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.

Secondary Outcome Measures

Full Information

NCT ID

NCT05340114

First Posted

April 15, 2022

Last Updated

April 15, 2022

Sponsor

Bioscan Research Pvt. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05340114

Brief Title

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

Official Title

Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 25, 2022 (Anticipated)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioscan Research Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Intracranial Hemorrhages

Keywords

Ease of Use, Ease of Learning, Satisfaction

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects examined by the operations with CEREBO®

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CEREBO®

Intervention Description

Near-infrared based point-of-care portable intracranial hematoma detector

Primary Outcome Measure Information:

Title

To evaluate the summative usability of CEREBO®

Description

Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bioscan Research

Phone

7948994429

Ext

info@bioscanresearch.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Jaimin Shah

Organizational Affiliation

Civil Hospital India

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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