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NCT03353246 · ClinicalTrials.gov registry record · NA

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
500
Enrollment target

NCT03353246: Completed NA study, sponsored by Duke University.

NCT03353246 is a NA study that has completed, run by Duke University. The registered enrollment target is 500 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03353246, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
500 participants
Enrollment target

Study 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).

Primary Outcome

Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.

Interventions

  • DEVICE InfraScanner 2000™

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2017-12-11
Est. Completion 2018-05-04
Phase NA
Duke University

1,725 total trials

What the finished NCT03353246 record still lists

NCT03353246 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 1 intervention - of which InfraScanner 2000™ is the first listed.

NCT03353246 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03353246 about?

NCT03353246 is a clinical study titled "Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas". 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...

What is the current status of trial NCT03353246?

This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2017-12-11. Estimated completion is 2018-05-04.

What interventions are being tested in trial NCT03353246?

The interventions under investigation include: InfraScanner 2000™ (DEVICE).

Who is sponsoring clinical trial NCT03353246?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03353246's enrollment target sits among peer trials

500 193rd of 2000 higher than 1,788 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03353246, the US trial registry maintained by the National Library of Medicine. NCT03353246 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.