Waste OutputNCT05438199
Prototyping a Device for Automating Stool and Urine Output Tracking
A study testing Toilet seat that measures waste output in people with Waste Output, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Waste Output
- What is being tested?
- Toilet seat that measures waste output
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27708
Veronica Palacios, 9197041523, veronica.palacios@duke.edu
Lawrence David
About this study
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
- Being tested
- Toilet seat that measures waste output
- Keywords
- urine output, stool output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toilet seat that measures waste outputDevice
Participants will use a toilet that includes a apparatus designed to measure waste output.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Toilet seat that measures waste output |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months
Secondary outcomes (2)
Percent of urine weight correctly identified by toilet seat apparatus
Measured by comparing participant weight loss before and after toilet use
Measured: Up to 3 months
Percent of stool weight correctly identified by toilet seat apparatus
Measured by comparing participant weight loss before and after toilet use
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start14 Nov 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waste OutputStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence David, Principal investigator, Duke University - MGM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438199
- Sponsor's protocol ID
- Pro00104899
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prototyping a Device for Automating Stool and Urine Output Tracking
- ClinicalTrials.gov ID
- NCT05438199
- Acronym / sponsor ID
- Pro00104899
- Conditions
- Waste Output
- Keywords
- urine output, stool output
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jun 2022 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apparatus use | Experimental | Device: Toilet seat that measures waste outputAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Toilet seat that measures waste outputParticipants will use a toilet that includes a apparatus designed to measure waste output. | Device | apparatus use |
Primary outcome
Percent of urine output correctly identified as measured by toilet seat apparatus .
Time frame: Up to 3 months
This analysis is intended to determine how accurately the apparatus measures urine output.
Percent of stool output correctly identified as measured by toilet seat apparatus .
Time frame: Up to 3 months
This analysis is intended to determine how accurately the apparatus measures stool output.
2 secondary outcomes
Percent of urine weight correctly identified by toilet seat apparatus
Time frame: Up to 3 months
Percent of stool weight correctly identified by toilet seat apparatus
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Lawrence David principal investigator
Duke University - MGM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toilet seat that measures waste output in people with Waste Output, run by Duke University at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lawrence David (919-668-5388, lawrence.david@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of urine output correctly identified as measured by toilet seat apparatus . (time frame: Up to 3 months). The study lists 2 primary outcomes in all. 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 12 Aug 2026.