ClinicalTrials.gg
CompletedNCT05008640Updated Aug 17, 2021

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

An observational study in Urinary Tract Infections, Infectious Diarrhea and Clostridium Difficile Infection, sponsored by Toi Labs, Inc.. Completed at 6 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-17.

Sponsored by Toi Labs, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
143
Ages
55 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Urinary Tract Infections
  • Infectious Diarrhea
  • Clostridium Difficile Infection
  • Gastrointestinal Disease
  • GastroIntestinal Bleeding

Keywords

  • Geriatric
  • Gastroenterology
  • Urinary
03

In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 143 is below the median of 236 across 198 observational studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

This is the only study on the registry with Toi Labs, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population was comprised of subjects that belong to the same study group, regardless of symptoms, disease diagnosis or state. Furthermore, there was no stratification of the population by sex, age, race or disease severity.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
143 participants (actual)
Patient registry
No

Groups and cohorts

  • Study group (all subjects)

    All subjects belonged to the same study group, regardless of symptoms, disease diagnosis or state. Furthermore, there was no stratification of the population by sex, age, race or disease severity.

    Device: TrueLoo™

Interventions

  • DeviceTrueLoo™

    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.

06

What researchers measure

Primary outcomes

  1. Bowel movement and urinary event dataset creation

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

    Time frame: Week 16 - 30

Secondary outcomes

  1. Comparison with current methodologies

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

    Time frame: Week 16 - 30

Other outcomes

  1. Identification of anomalous toileting patterns in TrueLoo™ data

    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.

    Time frame: Week 16 - 30

07

Study locations

6 sites
  • Carlton Senior Living (Concord)
    Concord, California 94520, United States
  • Carlton Senior Living (Davis)
    Davis, California 95618, United States
  • Carlton Senior Living (Elk Grove)
    Elk Grove, California 95758, United States
  • Eskaton Village Carmichael
    Sacramento, California 95608, United States
  • Eskaton Lodge Cameron Park
    Sacramento, California 95682, United States
  • Masonic Homes
    Union City, California 94587, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05008640
Lead sponsor
Toi Labs, Inc.
Responsible party
Sponsor
First posted
Aug 17, 2021
Start date
Nov 14, 2019
Primary completion
Jun 1, 2021
Completion
Jun 18, 2021
Last update
Aug 17, 2021

Study contacts

Paul F Cristman, PhD, MS, BS
principal investigator · Toi Labs, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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