NCT05340114

Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector

Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction

• 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 (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.

Detailed description

This prospective study determines the usability of CEREBO® to detect the intracranial hematoma. The operators will receive a training session before the study and will be evaluated at the end of the study through a survey questionnaire for ease of use, ease of learning and satisfaction. Each operator will examine at least 10 subjects with CEREBO®.

Conditions

• Traumatic Brain Injury
• Intracranial Hemorrhages

Interventions

Type	Name	Description
DEVICE	CEREBO®	Near-infrared based point-of-care portable intracranial hematoma detector

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-04-30
• Completion: 2023-05-31
• First posted: 2022-04-21
• Last updated: 2022-04-21