Urinary Tract InfectionsNCT05008640
Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
An observational study of Urinary Tract Infections and Infectious Diarrhea, run by Toi Labs, Inc. at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Infectious Diarrhea, Clostridium Difficile Infection
- What is being tested?
- TrueLoo™
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Nov 2019to 18 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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™.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carlton Senior Living (Concord)
Concord, California, 94520
Carlton Senior Living (Davis)
Davis, California, 95618
Carlton Senior Living (Elk Grove)
Elk Grove, California, 95758
Eskaton Village Carmichael
Sacramento, California, 95608
Eskaton Lodge Cameron Park
Sacramento, California, 95682
Masonic Homes
Union City, California, 94587
About this study
Official 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
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.
- Conditions
- Urinary Tract Infections, Infectious Diarrhea, Clostridium Difficile Infection, Gastrointestinal Disease, GastroIntestinal Bleeding
- Being tested
- TrueLoo™
- Keywords
- Geriatric, Gastroenterology, Urinary
- Medical subject headings
- Urinary Tract Infections, Dysentery, Clostridium Infections, Gastrointestinal Diseases, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TrueLoo™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 16 - 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start14 Nov 2019
- Primary completion1 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toi Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul F Cristman, PhD, MS, BS, Principal investigator, Toi Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008640
- Sponsor's protocol ID
- 20191822
- Other IDs
- 20191822, TLSD-001
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05008640
- Acronym / sponsor ID
- 20191822
- Conditions
- Urinary Tract Infections, Infectious Diarrhea, Clostridium Difficile Infection, Gastrointestinal Disease, GastroIntestinal Bleeding
- Keywords
- Geriatric, Gastroenterology, Urinary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Toi Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group (all subjects) | – | Device: TrueLoo™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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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™.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrueLoo™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. | Device | Study group (all subjects) |
Primary outcome
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.
1 secondary outcome
Comparison with current methodologies
Time frame: Week 16 - 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Cristman, PhD, MS, BS principal investigator
Toi Labs, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Infectious Diarrhea, run by Toi Labs, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel movement and urinary event dataset creation (time frame: Week 16 - 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.