Prototyping a Device for Automating Stool and Urine Output Tracking

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05438199
Collaborator
(none)
48
1
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Toilet seat that measures waste output
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Prototyping a Device for Automating Stool and Urine Output Tracking
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: apparatus use

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

Outcome Measures

Primary Outcome Measures

  1. Percent of urine output correctly identified as measured by toilet seat apparatus . [Up to 3 months]

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

  2. Percent of stool output correctly identified as measured by toilet seat apparatus . [Up to 3 months]

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

Secondary Outcome Measures

  1. Percent of urine weight correctly identified by toilet seat apparatus [Up to 3 months]

    Measured by comparing participant weight loss before and after toilet use

  2. Percent of stool weight correctly identified by toilet seat apparatus [Up to 3 months]

    Measured by comparing participant weight loss before and after toilet use

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Lawrence David, Duke University - MGM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05438199
Other Study ID Numbers:
  • Pro00104899
First Posted:
Jun 29, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Duke University

Study Results

No Results Posted as of Aug 15, 2022