Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls (NCT05812339) | Clinical Trial Compass
By InvitationNot Applicable
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Canada200 participantsStarted 2022-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.