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

Not Applicable

Completed

• Conditions: Gastric Emptying
• Interventions: Diagnostic Test: Scintigraphic gastric emptying scan; Device: Wireless patch system (WPS)

• Registration Number: NCT05555407
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-26
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wireless patch system (WPS)	Scintigraphic gastric emptying scan	Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.
Wireless patch system (WPS)	Wireless patch system (WPS)	Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States