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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motility Disorder Patients | Adults with history of confirmed motility disorder. |
| |
| Healthy Controls | Adults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric electrical signal frequency | Successful detection of gastric electrical signal in the 2-5 cycle-per-minute (cpm) spectrum as defined by reference ranges at Reliability of 90% and Confidence Interval (CI) of 95% | Pre-meal |
| Gastric electrical signal frequency | Successful detection of gastric electrical signal in the 2-5 cycle-per-minute (cpm) spectrum as defined by reference ranges at Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 1 hour |
| Gastric electrical signal frequency | Successful detection of gastric electrical signal in the 2-5 cycle-per-minute (cpm) spectrum as defined by reference ranges at Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 2 hours |
| Gastric electrical signal frequency | Successful detection of gastric electrical signal in the 2-5 cycle-per-minute (cpm) spectrum as defined by reference ranges at Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 3 hours |
| Gastric electrical signal frequency | Successful detection of gastric electrical signal in the 2-5 cycle-per-minute (cpm) spectrum as defined by reference ranges at Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 4 hours |
| Gastric electrical signal amplitude | Estimation of the power of the gastric electrical signal in the above frequency spectrum (μV) at a Reliability of 90% and Confidence Interval (CI) of 95% | Pre-meal |
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Inclusion Criteria:
Healthy Population:
Patient Population:
Exclusion Criteria:
Healthy Population:
Patient Population:
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Adults living in the Calgary Alberta region.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher N Andrews, MD MSc FRCPC | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
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|
| Gastric electrical signal amplitude | Estimation of the power of the gastric electrical signal in the above frequency spectrum (μV) at a Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 1 hour |
| Gastric electrical signal amplitude | Estimation of the power of the gastric electrical signal in the above frequency spectrum (μV) at a Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 2 hours |
| Gastric electrical signal amplitude | Estimation of the power of the gastric electrical signal in the above frequency spectrum (μV) at a Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 3 hours |
| Gastric electrical signal amplitude | Estimation of the power of the gastric electrical signal in the above frequency spectrum (μV) at a Reliability of 90% and Confidence Interval (CI) of 95% | Post meal at 4 hours |
| Safety - abdominal skin effects | Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal | After removal of Gastric Alimetry array at approximately 4.2 hours post meal |
| Safety - abdominal skin effects | Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal | 24 hours post study visit |
| Safety - abdominal skin effects | Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal | 7 days post study visit |
| Upper Gastric Symptoms - nausea, bloating, upper gut pain, heartburn, stomach burn, excessively full | Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable | Pre-meal |
| Upper Gastric Symptoms - nausea, bloating, upper gut pain, heartburn, stomach burn, excessively full | Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable | Post meal at 1 hour |
| Upper Gastric Symptoms - nausea, bloating, upper gut pain, heartburn, stomach burn, excessively full | Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable | Post meal at 2 hours |
| Upper Gastric Symptoms - nausea, bloating, upper gut pain, heartburn, stomach burn, excessively full | Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable | Post meal at 3 hours |
| Upper Gastric Symptoms - nausea, bloating, upper gut pain, heartburn, stomach burn, excessively full | Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable | Post meal at 4 hours |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| C536228 | Familial cyclic vomiting syndrome |
| D000096704 | Cannabinoid Hyperemesis Syndrome |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002189 | Marijuana Abuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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