Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT05092295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2021-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
Sponsor:
Rebiscan, Inc.
Organization:
Study Overview
Official Title:
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: