NCT05183529已完成不适用
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography
Celero Systems, Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the ability of the VM Pill to monitor respiration from within the GI tract
研究概览
简要总结
This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study.
排除标准
- •Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to:
- •Constipation
- •Esophageal stricture
- •Esophagitis
- •Gastritis
- •Gastric ulcers
- •Peptic ulcer
- •Gallstones
- •Celiac Disease
- •Crohn's Disease
- •Ulcerative Colitis
- •Irritable Bowel Syndrome
- •Diverticulitis
- •Colorectal cancer
结局指标
主要结局
Evaluate the ability of the VM Pill to monitor respiration from within the GI tract
时间窗: During polysomnography
Mean absolute error between respiratory rate measured by the VM Pill and respiratory rate measured by PSG monitoring equipment during periods of normal breathing while the patient is sleeping or at rest.
次要结局
未报告次要终点
研究者
研究点 (2)
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