Trials / Enrolling By Invitation
Enrolling By InvitationNCT05812339
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
- Motility Disorder
- Gastroparesis
- Functional Dyspepsia
- Cyclical Vomiting
- Cannabinoid Hyperemesis Syndrome
- Diabetic Gastroparesis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gastric Alimetry System | 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. |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2023-04-13
- Last updated
- 2024-12-05
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05812339. Inclusion in this directory is not an endorsement.