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

Usability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05340127
• Other study ID #: BR/US/2022/001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: Bioscan Research Pvt. Ltd.
• Contact: Bioscan Research
• Phone: 7948994429
• Email: info[@]bioscanresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages
• Usability

Intervention

Device:
• CEREBO®
Usability Study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioscan Research Pvt. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the rapidity of CEREBO® to detect intracranial haemorrhage	The time to perform the CEREBO® scan per subject will be determined	2 week