Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.
研究概览
简要总结
While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.
详细描述
This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU. Specifically, this study will:
- Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3 hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments (temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation, and adverse events, as reflected in the Table 1.0, Time and Events Table.
Additional safety assessments will be performed following the final removal of the CSD from the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.
- Assess the HCP's impression of likely safety and effectiveness (Function Assessments) of the CSD based on experience working with infants in the NICU, Evaluate/Rate the form and fit, and evaluate/rate the ease of application of the product.
- Collect additional feedback (if any) on HCP's impressions of device design and usability based on experience working as a HCP in the NICU
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
- •Be > 30.0 weeks gestational age at time of enrollment into the study
- •Be in medically stable condition within the NICU
- •Be able to breathe adequately on room air without support
- •Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
- •Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit
排除标准
- •The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
- •The patient has any genetic dermatological conditions
- •The patient's head size is not appropriate for the device < 28 centimeters or >34.3 centimeters (< 11 or > 13.5 inches)
- •Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.) that makes participating in the study not in the patient's best interest
结局指标
主要结局
HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.
时间窗: Each patient will spend approximately six (6) hours in the study if no adverse experiences
Rating scale data will be collected and analyzed using descriptive statistics to determine overall HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device. No hypothesis testing will be conducted. Only descriptive statistics, frequency counts, and proportions will be used to summarize the data. Descriptive statistics, such as number of observations, means, standard deviations, medians, and maximum and minimum values, will be used to summarize the continuous variables. Frequencies and proportions will be used to summarize categorical variables.
次要结局
未报告次要终点