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

Mayo Clinic

Status: Completed

Conditions: Gastric Emptying

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05555407

22-004957

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Wireless patch system (WPS)

Experimental group

Description:

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

Treatment:

Diagnostic Test: Scintigraphic gastric emptying scan

Device: Wireless patch system (WPS)