Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06335758
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication.
Sponsor:
Dosentrx Ltd.
Organization:
Study Overview
Official Title:
Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.
Status:
RECRUITING
Status Verified Date:
2023-12
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:
RegStud
Brief Summary:
The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
* treatment duration
* adverse events
* patient adherence and compliance
* engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.
The study will evaluate and monitor use of ReX in respect of:
* treatment duration
* adverse events
* patient adherence and compliance
* engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.
Detailed Description:
The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:
* Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
* Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
* Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.
ReX manages and monitors medication-based therapy by means of:
* Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
* Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
* Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.
In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.
Data collected by the ReX Remote Digital Nurse include:
* medication name
* prescribed dosage
* doses taken per day
* pills taken per dose
* ePRO responses
* missed pill intakes
* Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
* Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
* Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.
ReX manages and monitors medication-based therapy by means of:
* Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
* Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
* Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.
In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.
Data collected by the ReX Remote Digital Nurse include:
* medication name
* prescribed dosage
* doses taken per day
* pills taken per dose
* ePRO responses
* missed pill intakes
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?: