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

NCT00576147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2018-11-07

Study results available
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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

Conditions

  • TBI (Traumatic Brain Injury)

Interventions

DEVICE

Infrascanner

The main Near-Infrared spectroscopy (NIRS) head measurement

Sponsors & Collaborators

  • InfraScan, Inc.

    lead INDUSTRY

Principal Investigators

  • Claudia Robertson, MD · Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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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 NCT00576147 on ClinicalTrials.gov