NCT06240650已完成不适用
Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx
Celero Systems, Inc.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月26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
- 10
- 试验地点
- 2
- 主要终点
- The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.
研究概览
简要总结
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Healthy individuals ages 18 - 75 inclusive
- •Subject is a suitable candidate for study participation in the opinion of the Investigator
- •Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB
排除标准
- •Subjects with a history of any condition that may impact the GI tract
- •Subjects who are unable to swallow a 000 sized capsule
- •Subjects with an implanted medical device that has wireless data communication capability
- •Subjects planning to undergo an MRI within 30 days after the study
- •Subjects with a BMI > 40 (severe obesity)
- •Subjects who are pregnant or are nursing
- •Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment
结局指标
主要结局
The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects.
时间窗: day 1
次要结局
未报告次要终点
研究者
研究点 (2)
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