A clinical study to assess the diagnostic performance of CEREBO® in detecting intracranial hematoma non-invasively.

Not Applicable

• Conditions: Health Condition 1: S068- Other specified intracranial injuries

• Registration Number: CTRI/2022/04/041634
• Lead Sponsor: Dr Jaimin Shah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with a head injury referred for a CT scan within 72 hours from the onset of first symptoms of closed head injury

Exclusion Criteria

1. Patients with scalp bruises or scalp hematoma

2. History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of CEREBO® <br/ ><br>Specificity of CEREBO® <br/ ><br>Accuracy of CEREBO® <br/ ><br>Positive and Negative Predictive Value of CEREBO® <br/ ><br>Timepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
Categorisation of intracranial hematoma based on the bleed volume and depth of hematoma using CEREBO® <br/ ><br>Perform the usability studyTimepoint: 1 year