NCT00781248已完成2 期
Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Nanovibronix
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- safety of device usage
研究概览
简要总结
The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
- •Subject is able to understand and answer the pain and discomfort questionnaires
- •Subject has been fasting for at least 12h prior to the insertion phase
- •Subject underwent a physical examination by the PI
- •Subject able, agrees and signs the Inform Consent Form (ICF)
排除标准
- •Subject has any history of dysphagia or esophageal disease
- •Subject used anti pain medications during the last week prior to the study date
- •Subject used Antibiotics during the last week prior to the study date
- •Subject with Asthma
- •Subject with chronic or acute nasal or throat disorder
- •Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
- •Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
- •Subject has any condition, which precludes compliance with study and/or device instruction for use
- •Subject is currently participating in another clinical study
结局指标
主要结局
safety of device usage
时间窗: 6 hours
Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase
时间窗: every 30 minutes for 6 hours
次要结局
- pain/Dicomfort during insertion and removal of the nasogastric tube(at t=0h and t=6h)
研究者
研究点 (1)
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