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NCT05340114 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05340114
Other study ID # BR/CV/2021/001
Secondary ID CTRI/2022/04/041
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 25, 2022
Est. completion date May 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
Health authority
Study type Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date May 31, 2023
Est. primary completion date April 30, 2023
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. 1. MBBS with Specialisation 2. MBBS 3. Nursing Staff 4. Others Subjects - 1. Subjects with suspected traumatic brain injury and GCS > 13 2. Of all ages and gender, have understood the study and gave a written informed consent. Exclusion Criteria: Subjects - 1. Subjects with active bleeding or scalp laceration 2. Subjects with large extracranial lesions

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CEREBO®
Near-infrared based point-of-care portable intracranial hematoma detector

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 evaluate the summative usability of CEREBO® Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators. 1 year
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