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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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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®.

Conditions

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Traumatic Brain Injury Intracranial Hemorrhages

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Subjects examined by the operations with CEREBO®

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

Group Type EXPERIMENTAL

CEREBO®

Intervention Type DEVICE

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

Interventions

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CEREBO®

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

Intervention Type DEVICE

Eligibility Criteria

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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.