Recruiting

Project TRUST

Sponsor:

Duke University

Code:

NCT05520346

Conditions

Fluid Output

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electronic Device for Toilet

Study Details

Brief 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.

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

Study ID

NCT05520346

Start date

Sep 13, 2023

Status verified date

Feb, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Age 18-80 years
3. Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient
4. Able to read/write English

Exclusion Criteria:

1. Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter.
2. Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning OR during HF treatment.
3. Women who are pregnant
4. Patient height < 5'3" if they are a patient within the Duke Cardiology Clinic
5. Disabled individuals using wheelchairs or transfer devices to use bathroom

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Device

Patients use toilet device to measure fluid output and self-report event types

no intervention: Control

Collection in standard hats + nurses visually assessing fluid volumes

Interventions

Electronic Device for Toilet

Device will be installed on toilet of patients will in hospital to measure all waste output.

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 ]

Central Contacts and Locations

Central contacts

Lauren Hill

919-668-2369lauren.hill@duke.edu

Amy Bush

+1 919 668 1085amy.bush@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Chenyu Lin

919-668-1000chenyu.lin@duke.edu

+1 919 684 8964

More Information

Sponsor

Duke University

Last update posted

Aug 10, 2026

Last verified

Feb, 2026

Keywords

  • toilet device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-10.