Summative Usability Study of CEREBO® - a Non Invasive Intracranial Hemorrhage Detector

Study Overview
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Brief Summary
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Traumatic brain injury is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury. Most of these patients do not present any symptom at the time of diagnosis thus delaying the detection. CEREBO®, a non-invasive, portable, rapid, point-of-care intracranial haemorrhage detector can avoid delayed detection by decreasing the time from injury to the initial CT scan. The study aims at assessing the summative usability of the device by determining its ease of use, ease of learning and satisfaction among the medical health professionals. The participants will be trained before the study and will be assessed periodically. Each participant will use the device on at least 10 subjects.

Detailed Description
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A prospective interventional study designed to assess the summative usability and rapidity of CEREBO® - a portable device to detect intracranial haemorrhage. 10 participants from a Primary Health Centre will be enrolled in this study. The participants will be trained by the study staff before the study. The participant will fill in a questionnaire periodically. At the end of the study, the statistical analysis will be performed on the recorded data to establish the ease of use, ease of learning and satisfaction.

Official Title
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Summative Usability Study of a Novel Device - CEREBO® for Non Invasive Detection of Intracranial Haemorrhage

Conditions
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Usability

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 Ayush Nurse Others Subjects Of all ages and gender, have understood the study and gave a written informed consent. Exclusion Criteria: Subjects Cognitively impaired subjects unable to understand the study procedure

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 study participants using CEREBO®<br>CEREBO® - A non-invasive intracranial haemorrhage detector Scan Duration - 40 seconds per subject Frequency - Every operator will perform CEREBO® scan on at least 10 different subjects Adverse Effect: None | Device: CEREBO®<br>* Usability Study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the usability of CEREBO® to detect intracranial haemorrhage | A questionnaire filled by the participants will be assessed by the study team to assess the ease of use, ease of learning and satisfaction | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the rapidity of CEREBO® to detect intracranial haemorrhage | The time to perform the CEREBO® scan per subject will be determined | 2 week | 

 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