Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
NCT06344416 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-03-12
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.
Conditions
- Any Solid Oral Medication
Interventions
- 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).
Sponsors & Collaborators
-
Dosentrx Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-30
- Primary Completion
- 2025-03-30
- Completion
- 2026-01-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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