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OpenTrials
Completed

NCT Number: NCT05008640

Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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™.

Exclusion criteria

  • 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).

Treatment and study plan

TrueLoo™

Device

TrueLoo™ is an Internet-connected, smart toilet seat that uses computer vision technology to log and capture daily bowel movements and urinations. This data is then categorized by physical excreta characteristics to train and develop machine learning algorithms that are intended to eventually identify significant changes in stool and urine in real-time.

Primary outcomes

  1. Bowel movement and urinary event dataset creation

    Time frame: Week 16 - 30

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

Secondary outcomes

  1. Comparison with current methodologies

    Time frame: Week 16 - 30

    Error rate of bowel movement and urinary event tracking from current caregiver-reported and self-reported methods.

Other outcomes

  1. Identification of anomalous toileting patterns in TrueLoo™ data

    Time frame: Week 16 - 30

    Number of bowel movement and urinary event anomalies observed by TrueLoo™; ad-hoc health history collection and urine sampling will determine the relevance of these events.

Sponsors and collaborators

Lead sponsor

Toi Labs, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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