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

Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05555407
• Other study ID #: 22-004957
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Diagnostic Test:
• Scintigraphic gastric emptying scan
Nuclear medicine scan that provides an assessment of gastric motility

Device:
• Wireless 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials