Sorrel 25R Injector - Sorrel Clinical Study Protocol
United States20 participantsStarted 2021-08-23
Plain-language summary
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
Who can participate
Age range18 Years ā 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age 18 to ⤠40 years.
Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.
Subject has no active signs/symptoms of a viral infection for 10 days prior to visit # 2.
Body Mass Index between 20 to 35 kg/m2 (inclusive).
Subject willing and able to comply with study procedures.
American Society of Anaesthesiology Physical status (ASA PS) classification 1
Exclusion Criteria:
Current use of aspirin at a daily dose \> 81 mg,
Current use of any medication that may adversely affect blood coagulation (i.e. warfarin, Xarelto, Eliquis etc.)
Presence of any tattoos, discoloration, acne, scars, bruises, cuts, abrasions, rashes, hernias, or inflammation within the skin or subcutaneous tissue of the abdomen that could interfere with the infusion of saline or observation of study results, at the discretion of the investigator..
History of significant skin allergy, irritation, or hypersensitivity to medical adhesives or adhesive tape.
History of significant allergic reaction to medical saline solution.
History of significant allergic reaction to the skin antiseptic solutions alcohol or chlorhexidine.
History of any neurologic disease that may affect the perception of pain/discomfort (stroke, peripheral neuropathy).
Current use of any medication that may affect the perception of pain/discomfort (opioids, NSAIDs, topical local anesthetics) atā¦