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Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

NCT03353246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2019-08-20

Study results available
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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).

Conditions

  • Head 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

Interventions

DEVICE

InfraScanner 2000™

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Haglund, MD, PhD · Duke University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2018-05-04
Completion
2018-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353246 on ClinicalTrials.gov