Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying

A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05555407

Enrollment

Registered

2022-09-26

Start date

2022-08-01

Completion date

2022-10-15

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Emptying

Keywords

Scintigraphy

Brief summary

The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).

Interventions

DIAGNOSTIC_TESTScintigraphic gastric emptying scan

Nuclear medicine scan that provides an assessment of gastric motility

DEVICEWireless patch system (WPS)

Wireless wearable patches applied to the abdomen after 3 small areas of the abdomen that connect to a recording device for a total of 6 days and subjects will track mealtimes, bowel movements, and sleep using an iPhone app.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.

Exclusion criteria

* Have had prior gastric or esophageal surgery. * Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy). * Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents). * Have been recently hospitalized for complications of diabetes or have a HgbA1c \> 10. * Have severe psychological distress preventing study participation. * Unable to read or understand the consent form.

Design outcomes

Primary

Measure	Time frame	Description
Subject willingness to wear a wireless patch system (WPS)	7 days	Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026