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

July 3, 2023 updated by: Brian Lacy, Mayo Clinic

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wireless patch system (WPS)
Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Brian Lacy, PhD, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-004957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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