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Enrolling by invitationNCT05812339Updated Oct 15, 2026

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

An observational study in Motility Disorder, Gastroparesis and Functional Dyspepsia, sponsored by University of Calgary. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by University of Calgary · Observational

Updated Oct 15, 2026Enrollment updatedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Motility Disorder
  • Gastroparesis
  • Functional Dyspepsia
  • Cyclical Vomiting
  • Cannabinoid Hyperemesis Syndrome
  • Diabetic Gastroparesis

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03

In context

Gastroparesis

323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 80 observational studies indexed under Gastroparesis.

Browse Gastroparesis studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults living in the Calgary Alberta region.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy Population:

  • Adults aged 18 years and over
  • Able to understand the risks/benefits of the study
  • Able to give written
  • No active gastrointestinal symptoms or pathology
  • Resides in the Calgary, Alberta area

Patient Population:

  • Adults aged 18 years and over
  • > 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

Exclusion Criteria:

Healthy Population:

  • Under 18 years of age
  • > 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
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceGastric 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.

06

What researchers measure

Primary outcomes

  1. 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%

    Time frame: Pre-meal

  2. 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%

    Time frame: Post meal at 1 hour

  3. 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%

    Time frame: Post meal at 2 hours

  4. 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%

    Time frame: Post meal at 3 hours

  5. 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%

    Time frame: Post meal at 4 hours

  6. 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%

    Time frame: Pre-meal

  7. 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%

    Time frame: Post meal at 1 hour

  8. 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%

    Time frame: Post meal at 2 hours

  9. 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%

    Time frame: Post meal at 3 hours

  10. 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%

    Time frame: Post meal at 4 hours

  11. Safety - abdominal skin effects

    Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal

    Time frame: After removal of Gastric Alimetry array at approximately 4.2 hours post meal

  12. Safety - abdominal skin effects

    Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal

    Time frame: 24 hours post study visit

  13. Safety - abdominal skin effects

    Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal

    Time frame: 7 days post study visit

  14. 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

    Time frame: Pre-meal

  15. 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

    Time frame: Post meal at 1 hour

  16. 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

    Time frame: Post meal at 2 hours

  17. 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

    Time frame: Post meal at 3 hours

  18. 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

    Time frame: Post meal at 4 hours

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Enrollment
200→400
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Enrollment 200→400

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05812339
Responsible party
Sponsor
First posted
Apr 13, 2023
Start date
Nov 1, 2022
Primary completion
Jul 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 15, 2026

Study contacts

Christopher N Andrews, MD MSc FRCPC
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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