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

Bioscan Research

Status: Unknown

Conditions: Traumatic Brain Injury; Intracranial Hemorrhages

Treatments: Device: CEREBO®

Study type: Interventional

Funder types: Industry

Identifiers

NCT05340114

CTRI/2022/04/041634 (Registry Identifier)

BR/CV/2021/001

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Subjects examined by the operations with CEREBO®

Experimental group

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

Treatment:

Device: CEREBO®