Status:
COMPLETED
Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500™ in Uganda
Lead Sponsor:
Duke University
Collaborating Sponsors:
Mbarara Regional Referral Hospital
Mayanja Memorial Hospital
Conditions:
Head Trauma
Crushing Skull Injury
Eligibility:
All Genders
12-99 years
Phase:
NA
Brief Summary
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the portable near-infrared-based device (portable NIR-based device), the InfraScanne...
Detailed Description
When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approachin...
Eligibility Criteria
Inclusion
- Any patient who presents to MRRH or MMH with suspected head trauma, who is able to, or who has a legally authorized representative who is able to consent in English, Swahili, or Luganda will be considered for this study.
Exclusion
- Patients for which wounds to their head are too large to properly use the InfraScanner 2500™ will be excluded from this study. Patients will also be excluded if hair cannot be appropriately parted to allow for the fiberoptic tips of the device to make direct contact with the scalp. Patients for whom it is not possible to obtain an Infrascan within 30 minutes of their CT imaging will also be excluded from the study.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06491173
Start Date
July 30 2024
End Date
March 30 2025
Last Update
April 23 2025
Active Locations (2)
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1
Mayanja Memorial Hospital
Mbarara, Uganda
2
Mbarara Regional Referral Hospital
Mbarara, Uganda