Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 1:10 PM
Study NCT ID:
NCT05737550
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
Sponsor:
Kontigo Care AB
Organization:
Study Overview
Official Title:
A Second Explorative Pilot Study Evaluating Usability and Functionality of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With Confirmed Substance Use Disorder (SUD)
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.
Detailed Description:
This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: