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

NCT05008640 | Completed

• 2 other identifiers: 20191822TLSD-001
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

Geriatric; Gastroenterology; Urinary

Outcome Measures

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.

  Week 16 - 30

Secondary Outcomes (1)

• Comparison with current methodologies

  Week 16 - 30

Other Outcomes (1)

• Identification of anomalous toileting patterns in TrueLoo™ data

  Week 16 - 30

Study Arms (1)

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

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 (all subjects)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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™.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Toi Labs, Inc.: lead

Study Sites (6)

Carlton Senior Living (Concord)

Concord, California, 94520, United States

Location

Carlton Senior Living (Davis)

Davis, California, 95618, United States

Location

Carlton Senior Living (Elk Grove)

Elk Grove, California, 95758, United States

Location

Eskaton Village Carmichael

Sacramento, California, 95608, United States

Location

Eskaton Lodge Cameron Park

Sacramento, California, 95682, United States

Location

Masonic Homes

Union City, California, 94587, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Dysentery; Clostridium Infections; Gastrointestinal Diseases; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gastroenteritis; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul F Cristman, PhD, MS, BS

  Toi Labs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 17, 2021
• Study Start: November 14, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 18, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (6)