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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-01-31

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.

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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.

Conditions

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Usability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Subjects examined by the study participants using 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

Group Type EXPERIMENTAL

CEREBO®

Intervention Type DEVICE

Usability Study

Interventions

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CEREBO®

Usability Study

Intervention Type DEVICE

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.