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Diagnostic Device

InfraScanner 2000™ for Head Injury

N/A
Waitlist Available
Led By Michael Haglund, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient who presents to MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes following ct scan
Awards & highlights

Study Summary

This study is evaluating whether a portable device can help detect intracranial hematomas in patients with head trauma.

Eligible Conditions
  • Traumatic Brain Injury
  • Head Injury
  • Head Trauma
  • Head Injuries
  • Minor Head Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes following ct scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes following ct scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status
Secondary outcome measures
Causes of Head Trauma as Identified Through the Medical Record
Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE)
Identify Reasons CT Not Performed
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InfraScanner 2000™Experimental Treatment1 Intervention
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
InfraScanner 2000™
2017
N/A
~1180

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,397 Total Patients Enrolled
Michael Haglund, MD, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
500 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
2021. "Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505293.
~192 spots leftby Apr 2025
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