Wireless monitoring of Placebo Smart Patch
Recruiting
18-65 years
All
Phase
N/A
50 participants needed
1 Location
Brief description of study
Errors in use of medication patches occurs when more than one is applied which can lead to an overdose or patch poisoning. This is common in patients with dementia and can have serious medical consequences. Detecting errors in real-time can prevent overdose and its complications.
This study is investigating the use of a new technological approach to detect errors or mistakes in patch application in real-time. This innovative approach investigates Bluetooth/RFID chip technology incorporated in a placebo patch and its ability to transmit data to a cloud-based monitoring portal.
Detailed description of study
This study will investigate the ability of the prototype device to signal to a dashboard, and assess the monitors ability to accurately determine the number of tags on-body.
Total participation will be up to 3 hours. Participants will be randomized and receive between zero (0) and three (3) non-medicated skin patch (e.g., band-aid) to be placed on their body. Participants will visit a studio apartment-style simulation space where they will engage in scripted activities of daily living (ADLs).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Healthy Volunteers
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Age: Between 18 Years - 65 Years
-
Gender: All
Inclusion
- Male aged 18 to 65 years.
- BMI within 18 - 32 kg/m^2
- Willing to wear placebo patch(es) for up to 3 hours
- Willing and able to provide signed informed consent
- Able to communicate well with investigator and comply with the study procedures, requirements, restrictions, and directions of the study staff.
- History or presence of clinically significant respiratory, GI, renal, hepatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders. The existence of any surgical or medical condition that, in the judgment of the clinical Investigator, might jeopardize the subject’s safety, tolerability or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Known hypersensitivity to, or intolerance of, commonly used skin patches (such as, lidocaine patch or estradiol patch)
- The subject is unwilling or unable to comply with the protocol or scheduled appointments.
- The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
Updated on
29 Aug 2024.
Study ID: 855069
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