An interventional study of ReX-C intervention and Standard of Care in Thromboembolism, sponsored by Dosentrx Ltd.. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Dosentrx Ltd. · Not applicable, Interventional, and Other
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-coagulation therapy for the treatment and prevention of thromboembolism.
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 providing real-time, reliable adherence data to caregivers and timely, personalized reminders to patients.
During the study, the use of ReX-C system to receive medications will be compared to Standard of Care. Patients' adherence will be evaluated for both methods.
288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.
This study's planned enrollment of 100 is below the median of 173 across 155 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Dosentrx Ltd. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
Exclusion Criteria:
Subject is at end stage or terminal illness with anticipated of 6 months or less.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage.
Device: ReX-C intervention · Other: Standard of Care
Subjects start with Standard of Care stage followed by ReX-C Intervention.
Device: ReX-C intervention · Other: Standard of Care
Patients receive medication by the ReX-C device
Patients receive medication as usual
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire.
Time frame: 18 weeks
Ease of use and acceptance of ReX-C system measured by a questionnaire
Patients will be asked about their experience with ReX-C.
Time frame: 18 weeks
ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
Any event of delayed pill intake recorded by ReX-C should lead to a personal reminder to patient, who has to confirm the delay and act to take the missing dose.
Time frame: 18 weeks
Adherence rate measured by patient's plasma drug level
A comparison of adherence rate, measured by patient's plasma drug level, between ReX intervention stage and Standard of Care stage
Time frame: 18 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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