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

Not Applicable

• Conditions: Usability
• Interventions: Device: CEREBO®

• Registration Number: NCT05340127
• Lead Sponsor: Bioscan Research Pvt. Ltd.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Study Start: 2022-04-20
• Study First Posted: 2022-04-21
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects examined by the study participants using CEREBO®	CEREBO®	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

Primary Outcome Measures

Name	Time	Method
To assess the usability of CEREBO® to detect intracranial haemorrhage	2 week	A questionnaire filled by the participants will be assessed by the study team to assess the ease of use, ease of learning and satisfaction

Secondary Outcome Measures

Name	Time	Method
To assess the rapidity of CEREBO® to detect intracranial haemorrhage	2 week	The time to perform the CEREBO® scan per subject will be determined