NCT06344416

Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dosentrx Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 890.5050. and comprises the following components: 1. A disposable cartridge, a medication container supplied to participants pre-loaded with pills/capsules. The cartridge includes an integral mouthpiece, which dispenses the pill into the participant's 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 and/or text messages will be dispatched to the specified party.

Conditions

• Any Solid Oral Medication

Interventions

Type	Name	Description
DEVICE	Use of ReX to dispense and monitor solid oral medication therapy.	ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Timeline

• Start date: 2024-03-30
• Primary completion: 2025-03-30
• Completion: 2026-01-30
• First posted: 2024-04-03
• Last updated: 2025-03-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study