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NCT04505293 · 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
- 672
- Enrollment target
NCT04505293: Completed NA study, sponsored by Duke University.
NCT04505293 is a NA study that has completed, run by Duke University. The registered enrollment target is 672 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505293, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 672 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 Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
Primary Outcome
Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).
Interventions
- DEVICE InfraScanner 2000™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2022-08-05 |
| Phase | NA |
What the finished NCT04505293 record still lists
NCT04505293 is an interventional study that assigns participants to a tested intervention. The registered 672 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 (52% lower).
The record links to 0 conditions, and to 1 intervention - of which InfraScanner 2000™ is the first listed.
NCT04505293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04505293 about?
NCT04505293 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 NCT04505293?
This trial is currently completed. It is a NA study. The enrollment target is 672 participants. The study started on 2021-10-05. Estimated completion is 2022-08-05.
What interventions are being tested in trial NCT04505293?
The interventions under investigation include: InfraScanner 2000™ (DEVICE).
Who is sponsoring clinical trial NCT04505293?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04505293's enrollment target sits among peer trials
672 151st of 2000 higher than 1,849 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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