NCT06497088尚未招募不适用
A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body
Nasotrak Medical Pte Ltd4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray.
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
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
- •Adults greater than 18 years of age
- •Able to provide informed consent or have a legally authorized representative available to provide informed consent in English
- •Clinically requiring a 12 Fr NG/OG tube with X-ray confirmation per standard protocol
排除标准
- •Female subjects of childbearing age with known pregnancy or lactating.
- •Prisoners.
- •Unable to consent in English.
- •Subjects/ volunteers with pacemakers or life-sustaining devices in the body such as ICD.
- •Subjects with a history of:
- •Esophageal varices or ulcers.
- •Upper airway obstruction.
- •Upper GI stenosis or obstruction.
- •Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion.
- •Deformities of the sinus cavities and/or skull base.
- •Esophageal cancer or neoplasm.
结局指标
主要结局
Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray.
时间窗: 1 year
All patients will receive placement verification per institutional practice
次要结局
未报告次要终点
研究者
研究点 (4)
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