Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344416
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-21
Brief Title:
Open Label Controlled Post Marketing Registry Study of Ribociclib Ribo Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
Sponsor:
Dosentrx Ltd
Organization:
Dosentrx Ltd
Study Overview
Official Title:
Study of Ribociclib Ribo Treatment Adherence Clinical Study Protocol
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Primary Objective
To assess the persistence of ReX technology platform use measured by the percentage of participants who used ReX 1 throughout the study period and 2 before the treatment discontinuation
Secondary Objective
To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group
To assess the persistence of ReX technology platform use measured by the percentage of participants who used ReX 1 throughout the study period and 2 before the treatment discontinuation
Secondary Objective
To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group
Detailed Description:
The ReX Platform is a class 1 FDA listed device under product code NXB Dispenser Solid Medication as a device that meets the exempt regulation 21 CFR 8905050 and comprises the following components
1 A disposable cartridge a medication container supplied to participants pre-loaded with pillscapsules The cartridge includes an integral mouthpiece which dispenses the pill into the participants mouth following application of an inhalation
2 ReX Remote Digital Nurse ReX is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network
3 ReX Treatment Manager RTM is a web application used for the collection and management of data collected by the ReX
4 Reminders dispatched to participants and caregivers according to a predefined logic email SMS or via support team call
5 Electronic Patient Reported Outcomes ePROs questions tips reminders and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager
6 Thresholds in cases that participant reports exceed a predefined threshold notifications via email andor text messages will be dispatched to the specified party
1 A disposable cartridge a medication container supplied to participants pre-loaded with pillscapsules The cartridge includes an integral mouthpiece which dispenses the pill into the participants mouth following application of an inhalation
2 ReX Remote Digital Nurse ReX is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network
3 ReX Treatment Manager RTM is a web application used for the collection and management of data collected by the ReX
4 Reminders dispatched to participants and caregivers according to a predefined logic email SMS or via support team call
5 Electronic Patient Reported Outcomes ePROs questions tips reminders and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager
6 Thresholds in cases that participant reports exceed a predefined threshold notifications via email andor text messages will be dispatched to the specified party
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None