Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-04 @ 4:02 PM
Study NCT ID:
NCT02877732
Status:
TERMINATED
Last Update Posted:
2018-05-30
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The funding sponsor elected to terminate the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETA-TV
Brief Summary:
This is a prospective multi-center cohort feasibility and exploratory study.
Detailed Description:
Investigators propose to prospectively study a cohort of 18-25-year-old athletes to establish the reliability of EYE-SYNC data and the utility of the EYE-SYNC eye-tracking device as a sideline concussion assessment tool. The clinical research study will be conducted to 1) determine if eye-tracking, assessed on the sideline by EYE-SYNC eye-tracking device, is a potential marker of injury that can be used in conjunction with other sideline evaluations to inform decisions regarding removal of athletes from play and 2) to use the EYE-SYNC goggle data as a post- injury recovery monitor.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: