Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)

NCT05520346 | Recruiting FDA Device

• 1 other identifier: Pro00107848
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

toilet device

Outcome Measures

Primary Outcomes (1)

• Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment

  Up to 14 days

Secondary Outcomes (10)

• 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

  Up to 14 days

• Mean absolute error of urine volume (in mL) as measured by device

  Up to 14 days

• Time (in mins) spent handling/recording patient waste

  First 3 days of patient's HCT conditioning

• Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing

  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

  Up to 14 days

Study Arms (2)

Device

EXPERIMENTAL

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

Device: Electronic Device for Toilet

Control

NO INTERVENTION

Collection in standard hats + nurses visually assessing fluid volumes

Interventions

Electronic Device for Toilet DEVICE

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

Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Interventions

Bathroom Equipment

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Chenyu Lin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Hill

CONTACT

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

Amy Bush

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: September 13, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)