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

Study Overview
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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.

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®.

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

Conditions
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Traumatic Brain Injury, Intracranial Hemorrhages

Intervention / Treatment
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* Device: CEREBO®


Participation Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects examined by the operations with CEREBO®<br>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 | Device: CEREBO®<br>* Near-infrared based point-of-care portable intracranial hematoma detector<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ease of Use, Ease of Learning, Satisfaction