CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 672 enrolled
Drug / intervention
InfraScanner 2000™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04505293
NCT04505293N/ACompleted
CompareCT.gov

Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital and Mbarara Regional Referral Hospital: A Pilot Study

Duke University·interventional·Posted Aug 10, 2020·Updated Mar 19, 2024

In Brief

A clinical study evaluating InfraScanner 2000™ for Head Trauma and 15 related conditions. Completed, enrolled 672 participants across 2 sites in 2 countries.

Detailed Summary

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed, Head Trauma,Closed, Head Trauma Injury, Head Trauma, Penetrating, Head Injury, Minor, Head Injury Major, Head Injury, Open, Injuries, Craniocerebral, Injuries, Head, Multiple Head Injury, Trauma, Head
CountriesUganda, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 10, 2020
Enrollment StartOct 5, 2021
Primary CompletionJun 29, 2022
Study CompletionAug 5, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.9 years ago

Interventions

InfraScanner 2000™device

The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.