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

April 21, 2026 updated by: University of Calgary

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults living in the Calgary Alberta region.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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
  • History of allergy or intolerance to ingredients in the meal (nutrient drink, Ensure or similar and Clif bar or similar)
  • No vulnerable groups such as; prisoners, individuals with known cognitive impairment, or institutionalised individuals be involved
  • Regular cannabis use
  • Diagnosed with, or suspected to have life-threatening conditions that could result in immediate danger

Patient Population:

  • Under 18 years of age
  • BMI > 35
  • 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
  • Previous gastroduodenal surgery
  • 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
  • Pregnant women
  • History of allergy or intolerance to ingredients in the meal (nutrient drink, Ensure or similar and Clif bar or similar)
  • No vulnerable groups such as; prisoners, individuals with known cognitive impairment, or institutionalised individuals be involved
  • Regular cannabis use except in the case of CHS
  • Diagnosed with, or suspected to have life-threatening conditions that could result in immediate danger
  • Inability to remain in a relaxed reclined position for the test duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Motility Disorder Patients
Adults with history of confirmed motility disorder.
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.
Healthy Controls
Adults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric electrical signal frequency
Time Frame: Pre-meal
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
Time Frame: Post meal at 1 hour
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
Time Frame: Post meal at 2 hours
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
Time Frame: Post meal at 3 hours
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
Time Frame: Post meal at 4 hours
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
Time Frame: Pre-meal
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
Time Frame: Post meal at 1 hour
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
Time Frame: Post meal at 2 hours
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
Time Frame: Post meal at 3 hours
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
Time Frame: Post meal at 4 hours
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
Time Frame: After removal of Gastric Alimetry array at approximately 4.2 hours post meal
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
Time Frame: 24 hours post study visit
Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal
24 hours post study visit
Safety - abdominal skin effects
Time Frame: 7 days post study visit
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
Time Frame: Pre-meal
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
Time Frame: Post meal at 1 hour
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
Time Frame: Post meal at 2 hours
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
Time Frame: Post meal at 3 hours
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
Time Frame: Post meal at 4 hours
Self reported assessment of symptoms on a scale of 0-10 with 10 being most severe imaginable
Post meal at 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Christopher N Andrews, MD MSc FRCPC, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1925

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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