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

Assessment of Accuracy, Precision, and Feasibility of CEREBO® - a Near Infrared Light Device to detect and categorize the intracranial hematoma in patients with suspected brain injury compared to head CT scan as the gold standard:A prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/041634
Enrollment
250
Registered
2022-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S068- Other specified intracranial injuries

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Jaimin Shah
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patients with scalp bruises or scalp hematoma 2. History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap

Design outcomes

Primary

MeasureTime frame
Sensitivity of CEREBO® Specificity of CEREBO® Accuracy of CEREBO® Positive and Negative Predictive Value of CEREBO® Timepoint: 1 year—

Secondary

MeasureTime frame
Categorisation of intracranial hematoma based on the bleed volume and depth of hematoma using CEREBO® Perform the usability studyTimepoint: 1 year—

Countries

India

Contacts

Public ContactDr Jaimin Shah

Civil Hospital, Ahmedabad

jaimin_11@yahoo.com9825576967

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026