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

NCT05555407 | Completed

• 1 other identifier: 22-004957
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastric Emptying

Keywords

Scintigraphy

Outcome Measures

Primary Outcomes (1)

• Subject willingness to wear a wireless patch system (WPS)

  Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms

  7 days

Study Arms (1)

Wireless patch system (WPS)

EXPERIMENTAL

Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.

Diagnostic Test: Scintigraphic gastric emptying scan; Device: Wireless patch system (WPS)

Interventions

Scintigraphic gastric emptying scan DIAGNOSTIC_TEST

Nuclear medicine scan that provides an assessment of gastric motility

Wireless patch system (WPS)

Wireless patch system (WPS) DEVICE

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.

Wireless patch system (WPS)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Brian Lacy, PhD, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 26, 2022
• Study Start: August 1, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)