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

Not Applicable

• Conditions: Traumatic Brain Injury; Intracranial Hemorrhages
• Interventions: Device: CEREBO®

• Registration Number: NCT05340114
• Lead Sponsor: Bioscan Research Pvt. Ltd.

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®.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Study Start: 2022-04-25
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects examined by the operations with CEREBO®	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

Primary Outcome Measures

Name	Time	Method
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.