CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 431 enrolled
Drug / intervention
Infrascannerdevice
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/NCT00576147
NCT00576147N/ACompleted

A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

InfraScan, Inc.·interventional·Posted Dec 18, 2007·Updated Nov 7, 2018

In Brief

A clinical study evaluating Infrascanner for TBI (Traumatic Brain Injury). Completed, enrolled 431 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2007
Enrollment StartJul 1, 2006
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.5 years ago

Interventions

Infrascannerdevice

The main Near-Infrared spectroscopy (NIRS) head measurement