At a glance

ClinicalIndex Comparison Record

N/ACompleted· 500 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/NCT03353246

NCT03353246N/ACompleted

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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: A Pilot Study

Duke University·interventional·Posted Nov 27, 2017·Updated Aug 20, 2019

In Brief

A clinical study evaluating InfraScanner 2000™ for Head Trauma and 15 related conditions. Completed, enrolled 500 participants across 1 site.

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 Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).

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

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

201820192020202120222023202420252026

First PostedNov 2017

Enrollment StartDec 2017

Primary CompletionMay 2018

TodayJul 2026

First PostedNov 27, 2017

Enrollment StartDec 11, 2017

Primary CompletionMay 4, 2018

TodayJul 2, 2026

Enrollment to primary: 5 monthsPosted 8.6 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.