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

NCT05812339 | Enrolling By Invitation

• 1 other identifier: 19-1925
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (18)

• 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

• 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

Study Arms (2)

Motility Disorder Patients

Adults with history of confirmed motility disorder.

Device: Gastric Alimetry System

Healthy Controls

Adults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder.

Device: Gastric Alimetry System

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.

Healthy Controls; Motility Disorder Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living in the Calgary Alberta region.

You may qualify if:

• Healthy Population:
• Adults aged 18 years and over
• Able to understand the risks/benefits of the study
• Able to give written informed consent
• No active gastrointestinal symptoms or pathology
• Resides in the Calgary, Alberta area
• Patient Population:
• Adults aged 18 years and over
• BMI \> 35
• Able to understand the risks/benefits of the study
• Able to give written informed consent
• Patients meeting Rome IV Criteria for functional dyspepsia, or a nausea and vomiting disorder
• Patients with gastroparesis defined on a standardized gastric scintigraphy study
• Resides in the Calgary, Alberta area

You may not qualify if:

• Healthy Population:
• Under 18 years of age
• BMI \> 35
• Taking medications known to affect GI motility or the mid-gut axis (eg antidepressants, anti-anxiety medication, prokinetics, opiates)
• Metabolic, neurogenic, or endocrine disorders known to cause gastrointestinal dysmotility (eg. Multiple Sclerosis, Parkinson's disease, hypothyroidism)
• Known current GI infection (includes H. pylori when being actively treated)
• Known current inflammatory bowel disease
• Known current GI malignancy
• Known GI functional or motility disorders
• Previous gastroduodenal surgery
• GI functional or motility disorders
• Pregnant women
• Open abdominal wounds or abdominal skin not intact (eg rash, abrasions, weeping tissue)
• Fragile skin evidence by high susceptibility to skin tears or skin that bruises and breaks easily
• Allergy to adhesives

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Gastroparesis; Familial cyclic vomiting syndrome; Cannabinoid Hyperemesis Syndrome

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christopher N Andrews, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 13, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CA (1)