Feasibility Assessment of CEREBO - A machine learning powered near-Infrared Spectroscopy based device, in Traumatic Brain Injury: A Post Market Surveillance Study

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/04/065582

Enrollment

Registered

2024-04-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: CEREBO: A machine learning powered near infrared spectroscopy based device will be used to scan all patients with suspected TBI and referred for a head CT scan. Control Intervention1: N

Eligibility

Inclusion criteria

Inclusion criteria: Patients with suspected TBI referred for head CT scan

Exclusion criteria

Exclusion criteria: Patients with scalp bruises or hematoma.

Design outcomes

Primary

Measure	Time frame
Sensitivity, Specificity, Accuracy and other clinical parameters of CEREBO in detecting intracranial injury in TBITimepoint: 3 years	—

Secondary

Measure	Time frame
To assess the usability among healthcare professionals & operators & identify areas of improvement for specific use cases Timepoint: 3 years	—

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