Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 2:10 AM
Study NCT ID:
NCT06952569
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Factors Validation and Usability Testing of the IKE Age-Gating System
Sponsor:
IKE Tech
Organization:
Study Overview
Official Title:
Age-Gate Validation Functionality Testing of the IKE Application
Status:
COMPLETED
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:
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity, and gender, and asses the usability of the IKE System.
Detailed Description:
Study Objectives:
IKE developed a smartphone application which identifies and age-verifies users and works in conjunction with a Bluetooth low energy (BLE) chip to restrict connecting to and activating a device by a users age. The intention is to use this in ENDs devices, and therefore the age limit was set to 21 years. This feature is generally referred to as "age-gating."
The purpose of the study is to:
* Generally establish the ability of individuals to successfully download and use the IKE application
* Confirm the identification and age-verification application works effectively to prevent those under 21 from enabling the IKE application
* Confirm the identification and age-verification application works effectively to allow those 21 years of age or older to enable the IKE application
* Establish that only individual over 21 years of age is able to connect a device to the IKE application via Bluetooth
Upon successful Bluetooth connection to the device via the IKE application:
* Confirm the Maximum Idle Time function works by disconnecting the device and powering the device off within a maximum of 15 minutes
* Confirm the Out of Bluetooth Range function works specific to connection of the Vape device to the smartphone (Vape device will be placed in Faraday bag to force disconnect from smartphone) and the user can re-activate the device
* Confirm users are able to reactivate the same device after either Maximum Idle Time disconnect or Out of Bluetooth Range disconnect
Establish the ability of an identity and age-verified individual to log-in to the application on a secondary device (in this case a tablet) and effectively connect the device using Bluetooth while simultaneously forcing disconnection of the previously connected device
Further, the research is designed to have participants use the smartphone application in as natural as possible setting without direct instruction to simulate a real-world use setting.
IKE developed a smartphone application which identifies and age-verifies users and works in conjunction with a Bluetooth low energy (BLE) chip to restrict connecting to and activating a device by a users age. The intention is to use this in ENDs devices, and therefore the age limit was set to 21 years. This feature is generally referred to as "age-gating."
The purpose of the study is to:
* Generally establish the ability of individuals to successfully download and use the IKE application
* Confirm the identification and age-verification application works effectively to prevent those under 21 from enabling the IKE application
* Confirm the identification and age-verification application works effectively to allow those 21 years of age or older to enable the IKE application
* Establish that only individual over 21 years of age is able to connect a device to the IKE application via Bluetooth
Upon successful Bluetooth connection to the device via the IKE application:
* Confirm the Maximum Idle Time function works by disconnecting the device and powering the device off within a maximum of 15 minutes
* Confirm the Out of Bluetooth Range function works specific to connection of the Vape device to the smartphone (Vape device will be placed in Faraday bag to force disconnect from smartphone) and the user can re-activate the device
* Confirm users are able to reactivate the same device after either Maximum Idle Time disconnect or Out of Bluetooth Range disconnect
Establish the ability of an identity and age-verified individual to log-in to the application on a secondary device (in this case a tablet) and effectively connect the device using Bluetooth while simultaneously forcing disconnection of the previously connected device
Further, the research is designed to have participants use the smartphone application in as natural as possible setting without direct instruction to simulate a real-world use setting.
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?:
False
Is an FDA AA801 Violation?: