Prototyping a Device for Automating Stool and Urine Output Tracking

NCT05438199 | Recruiting FDA Device

• 1 other identifier: Pro00104899
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test an electronic apparatus for measuring stool and urine output in an accurate and easy way. Participants will have one in-person or virtual visit with the study team prior to starting the study events. Participants that enroll in this study will have the freedom to choose when to begin and stop using the toilet apparatus when it is available for human testing. This apparatus will be located in a private bathroom in either the CIEMAS building or MSRB III Building.

Conditions

Waste Output

Keywords

urine output; stool output

Outcome Measures

Primary Outcomes (2)

• Percent of urine output correctly identified as measured by toilet seat apparatus .

  This analysis is intended to determine how accurately the apparatus measures urine output.

  Up to 3 months

• Percent of stool output correctly identified as measured by toilet seat apparatus .

  This analysis is intended to determine how accurately the apparatus measures stool output.

  Up to 3 months

Secondary Outcomes (2)

• Percent of urine weight correctly identified by toilet seat apparatus

  Up to 3 months

• Percent of stool weight correctly identified by toilet seat apparatus

  Up to 3 months

Study Arms (1)

apparatus use

EXPERIMENTAL

All participants will use the apparatus following the same procedures. They will weigh themselves on a scale located in the bathroom, use the apparatus with or without "hats" ("hats" refer to a plastic container used to catch stool/urine that needs to be placed between the toilet rim and the toilet seat and discarded after each use) and weigh themselves after using the toilet.

Device: Toilet seat that measures waste output

Interventions

Toilet seat that measures waste output DEVICE

Participants will use a toilet that includes a apparatus designed to measure waste output.

apparatus use

Eligibility Criteria

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

You may qualify if:

• people who are able to use the private bathroom at no risk to themselves in the CIEMAS building (B508) or the bathroom located in room 4002, 4th floor of MSRB3.
• students or employees at Duke University since card access is required for our MSRB3 bathroom.
• people who spend most of their time in these buildings so we can assure the use of the toilet.
• If the recruitment number is slow, enrollment will include people from the closest buildings.

You may not qualify if:

• People who use wheelchairs or other mobility devices won't be able to enroll, since at this moment the bathroom is not compliant with the requirements on The Americans with Disabilities Act (ADA) of 1990.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Study Officials

• Lawrence David

  Duke University - MGM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence David

CONTACT

919-668-5388; lawrence.david@duke.edu

Veronica Carrion

CONTACT

9197041523; vmp19@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 29, 2022
• Study Start: November 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)