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OpenTrials
Completed

NCT Number: NCT05555407

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).

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Key information

Conditions

Gastric Emptying

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scintigraphic gastric emptying scan

Diagnostic Test

Nuclear medicine scan that provides an assessment of gastric motility

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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