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

Bioscan Research

Status: Unknown

Conditions: Usability

Treatments: Device: CEREBO®

Study type: Interventional

Funder types: Industry

Identifiers

NCT05340127

BR/US/2022/001

Details and patient eligibility

About

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.

Full 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.

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.
• 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

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 study participants using CEREBO®

Experimental group

Description:

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

Treatment:

Device: CEREBO®