Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

NCT04505293 | Completed Results FDA Device

• 1 other identifier: Pro00087011_1
• Study Type: interventional
• Target: 672
• Locations: 2 countries
• Sites: 2

Brief 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 Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.

Conditions

Head Trauma; Craniocerebral Injuries; Crushing Skull Injury; Head Injuries; Head Injuries, Multiple; Head Injuries, Closed; Head Trauma,Closed; Head Trauma Injury; Head Trauma, Penetrating; Head Injury, Minor; Head Injury Major; Head Injury, Open; Injuries, Craniocerebral; Injuries, Head; Multiple Head Injury; Trauma, Head

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status

  Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma).

  Within 30 minutes following CT scan

Secondary Outcomes (5)

• Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma)

  Within 30 minutes following CT scan

• Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma)

  Within 30 minutes following CT scan

• Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE)

  Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.

• Identify Reasons CT Not Performed

  Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.

• Causes of Head Trauma as Identified Through the Medical Record

  Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.

Study Arms (1)

InfraScanner 2000™

EXPERIMENTAL

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.

Device: InfraScanner 2000™

Interventions

InfraScanner 2000™ DEVICE

The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.

InfraScanner 2000™

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Related Publications (1)

• Liow YY, Ukachukwu AK, Iversen ES, Ordonez YT, Gramer R, Shlobin NA, Najjuma JN, Fuller AT, Haglund MM, Kitya D, Kolls BJ. Assessment of a Handheld Near-Infrared Light Device in Detecting Intracranial Hematomas in Mbarara, Uganda. Neurosurgery. 2025 Dec 8. doi: 10.1227/neu.0000000000003873. Online ahead of print.

  PMID: 41358727 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma; Head Injuries, Closed; Head Injuries, Penetrating

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Wounds, Penetrating

Results Point of Contact

• Title: Anthony 'Tony' T. Fuller, MD, MScGH
• Organization: Duke University

anthony.fuller@duke.edu

919-613-1813

Study Officials

• Michael Haglund, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 10, 2020
• Study Start: October 5, 2021
• Primary Completion: June 29, 2022
• Study Completion: August 5, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); UG (1)