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

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Enrollment increased: 200 → 400 participants
    • Eligibility criteria expanded, about 46 words
  2. Primary completion date: Dec 31, 2025 to Jul 2028
    • Study completion date: Dec 31, 2025 to Dec 2028
    v4
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v3
  4. Primary and study completion dates: Jul 31, 2024 to Dec 31, 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05812339
Lead Sponsor University of Calgary
Conditions
(from sponsor)		 Motility Disorder, Gastroparesis, Functional Dyspepsia, Cyclical Vomiting, Cannabinoid Hyperemesis Syndrome, Diabetic Gastroparesis
Related terms Cannabinoid Hyperemesis Syndrome, Familial cyclic vomiting syndrome, Gastroparesis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov