BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Device Performance
研究概览
简要总结
The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.
详细描述
This study is a monocentric, open-label, cross-over, feasibility and exploratory study with no acceptance criteria. Up to 70 healthy volunteers will be enrolled and followed up for 7 weeks at maximum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participants ≥ 18 years
- •BMI ≥18.5 kg/m2
- •Participant willing and able to complete all required study procedures and to provide informed consent
排除标准
- •Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).
- •Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit
- •Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment
- •Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology.
- •Participants who are pregnant, planning to become pregnant, or are breast-feeding.
结局指标
主要结局
Device Performance
时间窗: From device application until 15-minutes after injection
Change in adhesive pad adherence - device to skin/device to adhesive pad - determined via adherence scales (Score 0 - 4, whereby 0 is full adherence and 4 is reflecting full detachment)
Device Performance - Dose delivery efficiency
时间窗: After device removal
Determined by volume - measured via gravimetric analysis (weighing the device)
次要结局
- Tissue Effects(Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present)
- Additional OBI performance - Catheter condition(Approximately 15-minutes after device removal)
- Participant Pain(Immediately before device catheter is inserted, after insertion, during wear period, at start of injection, 15 minutes after injection, end of injection and upon removal for each applied device)
- Ultrasound Imaging of injection site(Baseline and immediately after procedure for each applied device)
- Adverse Events(Throughout study completion, an average of 4 week)
- Additional OBI performance - Injection signal/indicator performance(Before, during and after injection for each applied device; up to 28 hours after application)
- Participant Acceptability Questionnaires(Device acceptability questionnaire will be completed after device catheter is inserted, at 8 hours and 26 hrs after application, during Injection and upon device removal)