跳至主要内容
临床试验/NCT05008640
NCT05008640已完成不适用

TrueLoo™: Determining the Feasibility of an Electronic Bowel Movement and Urinary Event Log Via In Situ Categorization of Physical Properties of Stool and Urine

Toi Labs, Inc.6 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2019年11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
143
试验地点
6
主要终点
Bowel movement and urinary event dataset creation

研究概览

简要总结

The purpose of this study is to assess the feasibility of TrueLoo™, an Internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across Northern California.

详细描述

The logging and monitoring of bowel movements and urinary events is an important aspect of preventative care for residents in senior living facilities, providing early warning signs for conditions that may otherwise cause complications if dealt with reactively. However, this information is sporadically collected - if at all - and subjectively interpreted by caregivers, leading to inconsistencies and unreliable data. Toi Labs, Inc. has created TrueLoo™, an Internet-connected toilet seat, as a solution to these issues. TrueLoo™ acquires time-lapse images of a bowel movement or urinary event automatically and under controlled conditions. Residents enrolled in the current study will have a TrueLoo™ installed in their private bathroom, through which all bowel movements and urinary events will be tracked, anonymously, privately, and securely. As a result, an electronic bowel movement and urinary event log for each enrolled resident will be generated. Given sufficient data, the TrueLoo™ system will complete such electronic logs automatically, identify points in time where particular enrolled residents may have experienced anomalous toileting patterns, and determine the relevance of such events through targeted health history and urine sampling.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be willing to participate and provide consent for the study;
  • Must be a male or female, aged 55 or older;
  • Must be a resident of a senior living facility;
  • Must have regular access to a TrueLoo™.

排除标准

  • Candidates who are unwilling or unable to accept the requirements associated with installing TrueLoo™ in their residence, including power and Wi-Fi connectivity;
  • Candidates who use certain types of toileting assistance devices that at this time are not compatible with TrueLoo™ (e.g., padded toilet seat risers).

结局指标

主要结局

Bowel movement and urinary event dataset creation

时间窗: Week 16 - 30

Number of urinations and bowel movements exhibited from each participant during the study period, as observed by TrueLoo™ image analysis.

次要结局

  • Comparison with current methodologies(Week 16 - 30)

研究者

发起方
Toi Labs, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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