Fluid OutputNCT05520346
Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
A study testing Electronic Device for Toilet in people with Fluid Output, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Output
- What is being tested?
- Electronic Device for Toilet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to Aug 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic OR currently undergoing treatment for HF in the Duke Cardiology Clinic with order of strict I/O monitoring
- Age 18-80 years
- Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient
- Able to read/write English
Who cannot join
- Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter.
- Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning OR during HF treatment.
- Women who are pregnant
- Patient height < 5'3" if they are a patient within the Duke Cardiology Clinic
- Disabled individuals using wheelchairs or transfer devices to use bathroom
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, 27705
Chenyu Lin, 919-668-1000, chenyu.lin@duke.edu
+1 919 684 8964
About this study
The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets.
In this study, participants' hospital rooms will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.
- Conditions
- Fluid Output
- Being tested
- Electronic Device for Toilet
- Keywords
- toilet device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Device for ToiletDevice
Device will be installed on toilet of patients will in hospital to measure all waste output.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Patients use toilet device to measure fluid output and self-report event types Receives: Device: Electronic Device for Toilet |
| Control | No intervention | Collection in standard hats + nurses visually assessing fluid volumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
Measured: Up to 14 days
Secondary outcomes (7)
Correlation between daily patient fluid balance (difference between fluid input and output in mL) as measured by device measurements or standard of care nurse assessment and the change in daily weight
Measured: Up to 14 days
Mean absolute error of urine volume (in mL) as measured by device
Measured: Up to 14 days
Time (in mins) spent handling/recording patient waste
Measured: First 3 days of patient's HCT conditioning
Time (in mins) between nurse logging of patient urination in electronic medical records and device-based logging of patient urination
Measured: Up to 14 days
Percent of patients who indicated device satisfaction as measured by patient survey
Measured: Day 3 of HCT conditioning
Percent of nurses who indicated device satisfaction as measured by nurse survey
Measured: After transition to Stage 2 - about 3 days after patient begins HCT conditioning
Number of patient falls as measured by patient report
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start13 Sep 2023
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chenyu Lin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520346
- Sponsor's protocol ID
- Pro00107848
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2022
- Last updated
- 10 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
- ClinicalTrials.gov ID
- NCT05520346
- Acronym / sponsor ID
- Pro00107848
- Conditions
- Fluid Output
- Keywords
- toilet device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Aug 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 determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets.
In this study, participants' hospital rooms will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Electronic Device for ToiletPatients use toilet device to measure fluid output and self-report event types |
| Control | No intervention | –Collection in standard hats + nurses visually assessing fluid volumes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic OR currently undergoing treatment for HF in the Duke Cardiology Clinic with order of strict I/O monitoring
- Age 18-80 years
- Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient
- Able to read/write English
Key exclusion criteria (5 listed)
- Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter.
- Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning OR during HF treatment.
- Women who are pregnant
- Patient height < 5'3" if they are a patient within the Duke Cardiology Clinic
- Disabled individuals using wheelchairs or transfer devices to use bathroom
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 |
|---|---|---|
| Electronic Device for ToiletDevice will be installed on toilet of patients will in hospital to measure all waste output. | Device | Device |
Primary outcome
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
Time frame: Up to 14 days
7 secondary outcomes
Correlation between daily patient fluid balance (difference between fluid input and output in mL) as measured by device measurements or standard of care nurse assessment and the change in daily weight
Time frame: Up to 14 days
Mean absolute error of urine volume (in mL) as measured by device
Time frame: Up to 14 days
Time (in mins) spent handling/recording patient waste
Time frame: First 3 days of patient's HCT conditioning
Time (in mins) between nurse logging of patient urination in electronic medical records and device-based logging of patient urination
Time frame: Up to 14 days
Percent of patients who indicated device satisfaction as measured by patient survey
Time frame: Day 3 of HCT conditioning
Percent of nurses who indicated device satisfaction as measured by nurse survey
Time frame: After transition to Stage 2 - about 3 days after patient begins HCT conditioning
Number of patient falls as measured by patient report
Time frame: Up to 17 days
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 10 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.
Chenyu Lin, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Device for Toilet in people with Fluid 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 5 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 10 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 Lauren Hill (919-668-2369, lauren.hill@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment (time frame: Up to 14 days). 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 10 Aug 2026.