NCT03044301已完成不适用
Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Crossject
- 入组人数
- 97
- 主要终点
- depth of the injection by MRI
研究概览
简要总结
The aim of this study is to evaluate the performance of the ZENEO needle free device in subcutaneous functioning limits (low performance limit and high performance limit) and for intramuscular injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female healthy volunteers aged between 18 and 60 years,
- •affiliated to or covered by the French social security system,
- •BMI between ≥20 and ≤30 kg/m²
- •Patients without chronic medical or surgical illness
- •Patients with normal clinical examination at the screening visit,
- •Patients with normal blood pressure at the screening visit: systolic BP < 140 mmHg and diastolic BP < 90 mmHg, determined with the patient seated and resting for at least 5 minutes,
- •Patients within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study (only for MRI sub study volunteers),
- •Absence of cannabis, opiate, cocaine, amphetamine history (only for MRI sub study volunteers)
排除标准
- •history of drug abuse
- •history of hypersensitivity (disease or drug)
- •treatment with platelet inhibiting drugs within one week before inclusion
- •treatment with anticoagulant within four weeks before inclusion
- •subject likely to take any medication during the study
- •contra-indication to MRI: metallic intra-corporeal devices, claustrophobia
- •prior participation to other interventional clinical research within 3 months
- •in custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.
结局指标
主要结局
depth of the injection by MRI
时间窗: 5 minutes after the injection
次要结局
未报告次要终点
研究者
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