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Enrolling by Invitation

NCT Number: NCT05812339

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

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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Key information

Conditions

Motility Disorder Cannabinoid Hyperemesis Syndrome Chemically-Induced Disorders Cyclical Vomiting Diabetic Gastroparesis Digestive System Diseases Familial cyclic vomiting syndrome Functional Dyspepsia Gastrointestinal Diseases Gastroparesis Marijuana Abuse Mental Disorders Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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%

  2. 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%

  3. 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%

  4. 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%

  5. 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%

  6. 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%

  7. 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%

  8. 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%

  9. 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%

  10. 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%

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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