CompletedNot Applicable

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

United States500 participantsStarted 2017-12-11

Plain-language 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).

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study. Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan

Trial details

NCT IDNCT03353246

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-04

Results submitted2019-05-03

View on ClinicalTrials.gov More Head Trauma trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study. Exclusion Criteria: * None

What they're measuring

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level

Timeframe: Up to 30 days after first CT scan

False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level

Timeframe: Up to 30 days after first CT scan