NCT06173063终止不适用
Safety and Effectiveness of A Novel Enteral Feeding System: Prospective Study.
Rockfield Medical Devices2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Volume of Enteral Feed Consumed Per Day
研究概览
简要总结
The goal of this interventional study is to obtain information on the safety and effectiveness of a novel enteral feeding system in adult users requiring at least a portion of their nutritional intake via enteral feeding. The main questions it aims to answer are:
- Can the device be used safely and effectively?
- Does use of the device impact on patient's quality of life?
Participants will use Mobility+ enteral feeding system as their enteral feeding method for the duration of the study and will record their experiences.
详细描述
The study will allow 25 participants to use the Mobility+ system for their feeding sessions over the course of 14 consecutive days, following an initial 7-day period where participants have time to trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Participants with Gastrostomy (G) tube or Jejunostomy (J) tubes
- •Participant must require enteral tube feeding every day, as determined at the time of study enrolment
- •Participant must use commercially available enteral formula with standard enteral feeding system(s) (gravity bag, bolus, pump or combination(s)), for some or all of their tube feeds, for daytime or day and night-time feeding
- •Participant must be EN dependent i.e., 500 ml minimum daily feed intake from EN
- •Participants must be able to swap from current system to Mobility+ for a minimum of two daily feeds per day for duration of study (Study days 1 -14)
- •Participant must be >= 18 to reflect the subset of the intended use population being evaluated
- •Participant must be willing to participate in the study and provide consent).
- •Participants must have been on an enteral feeding regime for a minimum of 10 weeks
- •Participants clinical functional capacity is adequate as determined by operator clinical judgement, to enable them to participate fully in the study
- •Participants are suitable candidates for using Mobility+ as determined by operator clinical judgement on participant enteral feeding needs (as per prescription) and alignment with Mobility+ Flow Rate Guide
排除标准
- •Participants who do not use commercially available enteral formula for some or all their formula needs
- •Participants unable/unwilling to provide consent
- •Participants whose enteral feeding needs do not match the offering of the Mobility+, as determined by operator clinical judgement
- •Participants who have inadequate clinical functional capacity, as determined by operator clinical judgement to participate fully in the study e.g. neuromuscular or neurodegenerative disorders, or developmental delay
- •Participants with very limited mobility, as determined by operator clinical opinion
结局指标
主要结局
Volume of Enteral Feed Consumed Per Day
时间窗: 14 days
Volume in mls of enteral feed consumed in total, and with Mobility+
次要结局
- Usability of Mobility+ (Volume)(14 days)
- Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+(14 days)
- Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+(14 days)
- Participant Perspective on Quality of Life(14 days)
- Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+(14 days)
- Usability of Mobility+ (kcal)(14 days)
研究者
研究点 (2)
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