To evaluate the clinical performance of CEREBO in detecting intracranial injury in patients with traumatic brain injury
Not Applicable
- Conditions
- Health Condition 1: S068- Other specified intracranial injuries
- Registration Number
- CTRI/2024/07/071639
- Lead Sponsor
- Bioscan Research Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with suspected TBI referred for head CT/MRI scan
Exclusion Criteria
Patients with scalp bruises and hematoma
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, Specificity, Accuracy and other parameters of CEREBO in determining presence or absence of an intracranial bleedTimepoint: 3 years
- Secondary Outcome Measures
Name Time Method 1. To assess the number of referrals that CEREBO could have prevented from other sites to the study site <br/ ><br>2. To assess the usability of CEREBO® among healthcare professionals through survey questionnairesTimepoint: 3 years