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NCT00576147 · ClinicalTrials.gov registry record · NA
A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
A NA study of TBI (Traumatic Brain Injury), sponsored by InfraScan.
- Completed
- Registry status
- NA
- Development phase
- 431
- Enrollment target
- 4
- Study locations
NCT00576147: Completed NA study of TBI (Traumatic Brain Injury), sponsored by InfraScan.
NCT00576147 is a NA study of TBI (Traumatic Brain Injury) that has completed, run by InfraScan. The registered enrollment target is 431 participants, above the 152-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (184% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576147, a NA study of TBI (Traumatic Brain Injury), has completed, sponsored by InfraScan.
- COMPLETED
- Registry status
- NA
- Development phase
- 431 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purposes of this study are: 1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
Primary Outcome
We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain. Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements.
Conditions Studied
Interventions
- DEVICE Infrascanner
Study Locations (4)
Maryland
- Johns Hopkins University - Baltimore
Ohio
- University of Cincinnati - Cincinnati
Pennsylvania
- The Hospital of the University of Pennsylvania - Philadelphia
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2006-07 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT00576147 record still lists
NCT00576147 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, above the 152-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (184% higher).
The record links to 1 condition, with TBI (Traumatic Brain Injury) appearing as the primary indexed condition, and to 1 intervention - of which Infrascanner is the first listed.
NCT00576147 reports a single indexed study location in Maryland, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00576147 about?
NCT00576147 is a clinical study titled "A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection". The purposes of this study are: 1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operat...
What is the current status of trial NCT00576147?
This trial is currently completed. It is a NA study. The enrollment target is 431 participants. The study started on 2006-07. Estimated completion is 2011-01.
What conditions does trial NCT00576147 study?
This clinical trial studies the following conditions: TBI (Traumatic Brain Injury).
What interventions are being tested in trial NCT00576147?
The interventions under investigation include: Infrascanner (DEVICE).
Who is sponsoring clinical trial NCT00576147?
This trial is sponsored by InfraScan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00576147 being conducted?
This trial has 4 study locations across Maryland, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00576147's enrollment target sits among peer trials
431 3rd of 20 higher than 18 of 20 other TBI (Traumatic Brain Injury) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TBI (Traumatic Brain Injury) 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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