Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls

Sponsor
University of Calgary
Study ID
NCT05812339
Status
Enrolling By Invitation

Conditions

  • Cannabinoid Hyperemesis Syndrome
  • Cyclical Vomiting
  • Diabetic Gastroparesis
  • Functional Dyspepsia
  • Gastroparesis
  • Motility Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Gastric Alimetry System — DEVICE
    Gastric Alimetry is a medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders. The device is indicated for use during the diagnostic work-up of patients reporting gastric symptoms, who are suspected of having an underlying gastric motility problem.

Study Details

This is an analytical validation observational cohort study is designed to provide evidence of: safety and reliability of Body Surface Gastric Mapping using the Gastric Alimetry System (GAS), normal reference values, and correlation of metrics with patient symptoms among healthy adults and patients diagnosed with upper abdominal motility disorders. GAS is intended to record, store, view and process gastric myoelectrical activity. This is a proprietary system consisting of multiple electrodes arranged on an array that is placed precisely over the stomach, a reader to collect the electrode measurements and a smart tablet application to track patient reported symptoms. Participants meeting inclusion and exclusion criteria will continue fasting for 30 minutes after the Gastric Alimetry System has been applied and begun measuring, eat a standard study meal within 10 minutes and remain quietly seated, reclining, for 4 hours as the GAS continues to collect data. The array is removed and the abdomen is examined for evidence of skin effects.

Key Dates

First listed
Apr 13, 2023
Start date
Nov 1, 2022
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Motility Disorder Patients
    Adults with history of confirmed motility disorder.
  • Arm: Healthy Controls
    Adults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder.

Primary Outcome Measure

Gastric electrical signal frequency [ Time Frame: Pre-meal ]

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