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

April 21, 2022 updated by: Bioscan Research Pvt. Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional 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®

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®
Usability Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the usability of CEREBO® to detect intracranial haemorrhage
Time Frame: 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
2 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioscan Research Pvt. Ltd.

Investigators

  • Principal Investigator: Dr.Kaushik Vitthlapara, PHC, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR/US/2022/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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