Motility DisorderNCT05812339
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
An observational study of Motility Disorder and Gastroparesis, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motility Disorder, Gastroparesis, Functional Dyspepsia
- What is being tested?
- Gastric Alimetry System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults living in the Calgary Alberta region.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Gastric Alimetry System
- Medical subject headings
- Gastroparesis, Familial cyclic vomiting syndrome, Cannabinoid Hyperemesis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Alimetry SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Motility Disorder Patients | Adults with history of confirmed motility disorder. Receives: Device: Gastric Alimetry System | |
| Healthy Controls | Adults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder. Receives: Device: Gastric Alimetry System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: Post meal at 4 hours
Safety - abdominal skin effects
Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal
Measured: 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
Measured: 24 hours post study visit
Safety - abdominal skin effects
Incidence of skin irritation from the electrodes / adhesive, discomfort associated with device wear or removal
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post meal at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Nov 2022
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility DisorderStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher N Andrews, MD MSc FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812339
- Sponsor's protocol ID
- 19-1925
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
- ClinicalTrials.gov ID
- NCT05812339
- Acronym / sponsor ID
- 19-1925
- Conditions
- Motility Disorder, Gastroparesis, Functional Dyspepsia, Cyclical Vomiting, Cannabinoid Hyperemesis Syndrome, Diabetic Gastroparesis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motility Disorder Patients | – | Device: Gastric Alimetry SystemAdults with history of confirmed motility disorder. |
| Healthy Controls | – | Device: Gastric Alimetry SystemAdults meeting all inclusion and exclusion criteria with no symptoms or history of motility disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living in the Calgary Alberta region.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (36 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Alimetry SystemGastric 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. | Device | Healthy Controls, Motility Disorder Patients |
Primary outcome
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%
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%
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%
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%
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%
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%
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%
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%
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%
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%
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher N Andrews, MD MSc FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motility Disorder and Gastroparesis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric electrical signal frequency (time frame: Pre-meal). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.