NCT05340127

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Bioscan Research Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Usability

Interventions

Type	Name	Description
DEVICE	CEREBO®	Usability Study

Timeline

• Start date: 2022-04-20
• Primary completion: 2022-12-31
• Completion: 2023-01-31
• First posted: 2022-04-21
• Last updated: 2022-04-22