NCT05221333Unknown不适用
Assessment of Safety and Performance of an Investigational Wearable Injector in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reliability of SWI
研究概览
简要总结
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 #
- •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
排除标准
- •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) at the discretion of the investigator.
- •Current use of any medical condition or medication that to the opinion of the investigator may affect the risk for a serious adverse event
- •Female of childbearing age with a positive pregnant test, or currently breast feeding.
- •Study subject refuses to allow clipping of excess abdominal hair at the site of device placement
- •Any current or unstable cardiac, pulmonary, hepatic, renal, neurologic, gastrointestinal, endocrine, immune, endocrine, musculoskeletal, coagulation disorder, or infectious disease which in the opinion of the Investigator would place the subject at risk or influence the conduct of the study, or interpretation of the results.
- •Current participation in another clinical drug or device study.
- •Inability of the subject to comply with all study procedures.
- •Inability of the subject to understand the information required for monitoring their infusion sites.
结局指标
主要结局
Reliability of SWI
时间窗: 24 hours
70% successful injection confirmed by visual inspection of investigator
次要结局
- Incidences of Treatment Emergent Adverse Events of SWI(1 month)
- Pain associated with use of SWI(1 month)
研究者
研究点 (2)
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