Status:
UNKNOWN
Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
Lead Sponsor:
Dosentrx Ltd.
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagula...
Detailed Description
ReX-C is a mobile system intended to provide solid, oral medication on patient demand, according to a pre-programmed treatment protocol. ReX-C addresses poor adherence to medication therapy by providi...
Eligibility Criteria
Inclusion
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- Subject receives anti-coagulants for the treatment and prevention of thromboembolism events, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)).
- Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
- Subject receives stable dose of medication for at least a month.
- Subject takes medication therapy at home.
Exclusion
- Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent Form or use the ReX-C dispensing unit effectively.
- Subject cen not use ReX-C to receive medications.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
- \-
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03424330
Start Date
January 9 2019
End Date
December 25 2023
Last Update
December 12 2023
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel, 3436212