Pilot Study of the Entarik System With Advanced Functionality in Health Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Freedom from device-related adverse events
研究概览
简要总结
In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •At least 18 years old
- •Able to provide informed consent
- •Capable and willing to follow all study-related procedures
- •Confirmed fasted state for a minimum of 8 hours prior to study initiation
排除标准
- •Inability to receive a feeding tube
- •Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
- •Has a basilar skull fracture
- •Self-reports pregnancy
- •Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
结局指标
主要结局
Freedom from device-related adverse events
时间窗: From enrollment to end of study (1 day)
The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study. Based on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.
次要结局
未报告次要终点