Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Completeness of injection
研究概览
简要总结
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
详细描述
Up to 400 children, ages 2 months through 14 years
- To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
- To document completeness of injections; completeness is defined as <10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
- To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants and children between ages 2 months and 14 years
- •Outpatient, expected to go home day of surgery
- •Written consent and assent when appropriate
- •Willing to complete and return pain diary (postcard) after 48 hours
排除标准
- •Presently have skin rash at the intended injection site
- •Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
- •Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
- •Skin disorders that may predispose them to develop skin lesions at sites of trauma.
- •Present use of any blood thinning medications.
- •In the 10-11 year old cohort, none of the participants can have started puberty.
结局指标
主要结局
Completeness of injection
时间窗: within one minute after injection
To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. Measurement of the bleb size following injection will recorded in millimeters.
Size of bleb on skin after injection
时间窗: within 2 minutes after injection
Measurement of the bleb size immediately following injection will be determined using a millimeter ruler
Acceptability by subject
时间窗: up to 48 hrs
subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia.
次要结局
未报告次要终点