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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05340114

Enrollment

Registered

2022-04-21

Start date

2022-04-25

Completion date

2023-05-31

Last updated

2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages, Traumatic Brain Injury

Keywords

Ease of Use, Ease of Learning, Satisfaction

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®.

Interventions

DEVICECEREBO®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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. 1. MBBS with Specialisation 2. MBBS 3. Nursing Staff 4. Others Subjects - 1. Subjects with suspected traumatic brain injury and GCS \> 13 2. Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion criteria

Subjects - 1. Subjects with active bleeding or scalp laceration 2. Subjects with large extracranial lesions

Design outcomes

Primary

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

Contacts

Primary ContactBioscan Research

info@bioscanresearch.com7948994429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026