Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT04993833
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inter-Device Reliability of the NPi-300 Pupillometer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Inter-Device Reliability of the NPi-300 Pupillometer
Status:
COMPLETED
Status Verified Date:
2022-09
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:
TRIPLE
Brief Summary:
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Detailed Description:
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.
If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: