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A study to assess the efficacy of a portable, non-invasive point of care device CEREBO® to detect the intracranial hematomas.

Assessment of Accuracy, Precision, and Feasibility of 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/2022/02/040208
Enrollment
250
Registered
2022-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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 Sumit Raj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients referred for a head CT scan from the trauma center within 72 hours from the onset of the 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® Positive and negative predictive Values of CEREBO® Timepoint: 6 months—

Secondary

MeasureTime frame
Categorisation of Intracranial bleeding based on the bleed depth and volumeTimepoint: 72 hours—

Countries

India

Contacts

Public ContactDr Sumit Raj

AIIMS Bhopal

sumit.neurosurg@aiimsbhopal.edu.in7354452548

Outcome results

None listed

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