A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers. The study will enroll up to 25 healthy adult subjects. Each subject will perform a maximum of 5 visits during the study over a period of approximately 2 months; a virtual visit for informed consent, two in-person visits for device evaluation, and two follow-up virtual visits to evaluate the skin and surrounding tissue for adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Use of Sorrel Wearable Injector in pilot study
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGReliability of SWI
70% successful injection confirmed by visual inspection of investigator
Time frame: 24 hours
Incidences of Treatment Emergent Adverse Events of SWI
Evaluation of AEs
Time frame: 1 month
Pain associated with use of SWI
Pain assessment based on visual analog scale (VAS), higher score means worse outcome
Time frame: 1 month
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