NCT00684333暂停不适用
Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Sindolor
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Study primary goal is to evaluate the safety of using the EZ-Ject Injector device for subcutaneous injections.The safety of using the EZ-Ject Injector device will be established by paucity of major complications that are device-related.
研究概览
简要总结
Subcutaneous injections are a widely used method for drug delivery. One of its major drawbacks is the pain inflicted during the process. Sindolor has developed the chemical-free EZ-Ject Injector device, based on employing cutaneous local anesthesia on the injection site by an electronic anesthetic system. The purpose of this study is to determine the safety and efficacy of the EZ-Ject for subcutaneous injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian males and females between 18 and 50 years of age.
- •Colour of skin that will enable to clearly observe dermal effects.
- •Non-pregnant, non-lactating female subjects whose urine screening pregnancy test is negative.
- •Subjects must be available to complete the study.
- •Subjects must satisfy a medical examiner about their fitness to participate in the study.
- •Subjects must provide written informed consent to participate in the study.
排除标准
- •Persons with a large amount of hair on the injection sites
- •Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions that could interfere with the observation of the injection sites.
- •History of skin allergy or hypersensitivity
- •History of severe skin infection in the past 1 year.
- •History of easy bruising.
- •Current or previous history of neurological disorders (particularly neuropathies), low back pain with neurological involvement.
- •Any psychological condition that could influence the conduct of the study or interpretation of results.
- •A history of drug or alcohol abuse
- •Use of alcohol or medications within 48 hours prior to and during study participation
- •Any condition, which in the opinion of the Principal Investigator or the study physician would place the subject at risk or influence the conduct of the study or interpretation of results.
- •Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
- •Pregnancy
结局指标
主要结局
Study primary goal is to evaluate the safety of using the EZ-Ject Injector device for subcutaneous injections.The safety of using the EZ-Ject Injector device will be established by paucity of major complications that are device-related.
时间窗: immediately
次要结局
- Study secondary goal is to asses the efficacy of using the EZ-Ject Injector device. Efficacy will be assessed by alleviating injection pain. Subjective discomfort and pain will be assessed by analogue pain scale (VAS Scale).(immediately)
研究者
研究点 (1)
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