Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000717651p
Ethics application status
Not yet submitted
Date submitted
14/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of body surface gastric mapping for the assessment of patients with gastrointestinal symptoms in New Zealand
Scientific title
The evaluation of body surface gastric mapping for the assessment of patients with gastrointestinal symptoms and healthy controls in New Zealand
Secondary ID [1] 308121 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is an expansion to a previous study registered at ClinicalTrials.gov (ID: NCT05812339)

Health condition
Health condition(s) or problem(s) studied:
Functional gastrointestinal disorders 327831 0
Functional Dyspepsia 327832 0
Chronic Nausea and Vomiting Syndrome 327833 0
Gastroparesis 327834 0
Condition category
Condition code
Oral and Gastrointestinal 324906 324906 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body Surface Gastric Mapping (BSGM) will be performed on all participants who enrol in this study. BSGM is a novel medical device for non-invasively assessing gastric motility, using a high-density array of 64 electrodes mounted on the epigastric skin. This BSGM provides a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency and pattern, in high spatiotemporal detail. The system also includes an App for tracking patient-reported symptoms throughout the test.

The study involves a simple test, "like an ECG for the gut" that will be conducted for a period from 90 minutes to five hours. The study is painless and non-invasive, although participants must keep still.
Participants will be asked to fast (not eat or drink anything including tea and coffee) overnight before their test (for at least 8 hours), and asked not to smoke or vape in the morning of their test. They may also be asked to refrain from taking some medications for 48 hours before their test. These medications include: drugs that affect gastric emptying (metoclopramide, domperidone, erythromycin), antispasmodics, pain medications which contain opiates (codeine, oxynorm, morphine, and tramadol), or sedatives. This is because these medications affect normal stomach actions.
Upon arrival, participants will be required to fill out questionnaires about their medical history, symptoms, and gastrointestinal-related quality of life.
Participants will also be asked to fill out questionnaires to assess anxiety, depression, stress and illness perceptions, since these factors have been found to be related to some GI problems. These questionnaires will be optional and will take approximately 15 minutes.
The BSGM recording will then be set-up:
A guide will be used to locate the array in a personalised manner. A portable ultrasound may be used to verify this positioning system is accurate.
Excess hair will be removed and participant’s skin will be prepped using NuPrep, which reduces skin impedance for enhanced test results.
A 64-channel electrode array (28 cm x 17 cm) will be non-invasively placed over the abdominal skin and connected to a portable data logger by a trained research assistant.
For some participants, the sensor array will also be connected to a second clinical recording device, if part of another study taking place at the same time (which will have separate ethical approval and trial registration).
For some participants, a second array will be placed over the lower abdomen in order to measure their colonic activity alongside their stomach activity. This will help differentiate signals from the stomach and colon.
Participants will be given a smartphone or tablet and be instructed on how to log symptom information throughout the study.
After around 30 minutes of baseline BSGM data is captured, the participant will be asked to consume a standardised meal of approximately 200-500 kCal. Suitable dietary options will be available for diabetics, people with dairy or gluten sensitivities, or people who are vegan.
The recording will continue between 60 to 240 minutes after the meal. A normal test has a 240minute post-meal recording; however, this can be shortened if the participant is unable to sit still for that amount of time. During this time the participant will be asked to sit in a reclined position and limit movement, talking, laughing or sleeping.
Once the recording has been finished, the sensor array(s) will be removed from the abdomen and disposed of.
Intervention code [1] 324580 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy volunteers will also be recruited for this study to compare their stomach activity with patients to assess differences. Healthy controls will be defined as those who have an absence of chronic gastrointestinal symptoms. The procedure will be the same for both controls and patients
Control group
Active

Outcomes
Primary outcome [1] 332718 0
BMI adjusted amplitude assessed via the BSGM procedure
Timepoint [1] 332718 0
Continuously during the BSGM procedure, at a maximum duration of 4.5 hours
Primary outcome [2] 335165 0
Gastric Alimetry Rhythm Index (GA-RI)- which characterises the rhythmic stability of the recorded gastric activity, assessed via the BSGM procedure
Timepoint [2] 335165 0
Continuously during the BSGM procedure, at a maximum duration of 4.5 hours
Primary outcome [3] 335166 0
Principal gastric frequency, assessed via the BSGM procedure
Timepoint [3] 335166 0
Continuously during the BSGM procedure, at a maximum duration of 4.5 hours
Secondary outcome [1] 423339 0
Total Symptom Burden measured via the validated Gastric Alimetry app
Timepoint [1] 423339 0
Every 15 minutes during the BSGM test
Secondary outcome [2] 423343 0
Fed:Fasted Amplitude Ratio (ff-AR) (Primary Outcome), assessed via the BSGM procedure
Timepoint [2] 423343 0
Continuously during the BSGM procedure, at a maximum duration of 4.5 hours

Eligibility
Key inclusion criteria
Are able to understand the risks/benefits of the study and able to give informed consent
Or minors under the age of 16 with parental/guardian informed consent, and child assent

Patients are defined as meeting the Rome IV Criteria for functional dyspepsia (FD) or chronic nausea and vomiting syndrome (CNVS), whilst healthy controls are defined as having an absence of chronic gastroduodenal symptoms.

Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females who are pregnant of lactating
People with a history of skin allergies or of extreme sensitivity to cosmetics or lotions
People with fragile skin evidenced by high susceptibility to skin tears or skin that bruises and breaks easily
People with open abdominal wounds or abdominal skin not intact (e.g. rash, abrasions, weeping tissues)
Patients unable to remain in a relaxed, reclined position for the test duration
No vulnerable groups such as; prisoners, individuals with known cognitive impairment, institutionalised individuals, or minors under the age of 16 without parental consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will establish normative data for the following features throughout the entire recording as well as for the fasting and postprandial periods:
slow-wave frequency
slow wave power or amplitude
rate of change of power
patterns of wave propagation including direction and speed.
response to meal
We will then assess what percentage of symptomatic patients fall outside the normative range and compare to their clinical diagnosis and disease aetiology. To compare results between groups, we will employ the two-sided Fisher’s exact test for the categorical variables and one-way analysis of variance (ANOVA) for continuous variables. We will also sub-type the electrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all participants. We will also determine the associations between all the study variables with Pearson’s correlation coefficient and will report statistically significant correlations after Benjamini-Hochberg correction (alpha=.05). Finally, we will build a model using BSGM features to try to predict temporal changes in patient reported symptoms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 25045 0
New Zealand
State/province [1] 25045 0
Auckland

Funding & Sponsors
Funding source category [1] 312375 0
Commercial sector/Industry
Name [1] 312375 0
Alimetry Ltd.
Country [1] 312375 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Alimetry Ltd.
Address
86 Symonds Street, Grafton,
Auckland, 1010, New Zealand
Country
New Zealand
Secondary sponsor category [1] 313946 0
None
Name [1] 313946 0
Address [1] 313946 0
Country [1] 313946 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311735 0
Health and Disability Ethics Committee (HDEC), Ministry of Health, New Zealand.
Ethics committee address [1] 311735 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311735 0
New Zealand
Date submitted for ethics approval [1] 311735 0
10/07/2023
Approval date [1] 311735 0
Ethics approval number [1] 311735 0

Summary
Brief summary
Study Objectives:

Aim 1: Establish normative data for BSGM in healthy controls.
We will enrol healthy asymptomatic controls to establish normative data for BSGM. Normative data will be from a reference population to establish a baseline distribution for various BSGM features, and against which the score or measurement in symptomatic patients can be compared. Normative data will be obtained from a large, randomly selected representative sample from the wider population including a wide range of age, body mass index, sex, and ethnicity.

Aim 2: Evaluate the association of symptoms to electrical activity in patients with gastrointestinal symptoms.
We will evaluate symptoms using validated questionnaires as well as tracking continuous changes in symptoms using a custom-designed App supplied on an iPad mini and paired to the BSGM device using Bluetooth. We will correlate associations between patient reported symptoms and BSGM, for patients with normal and abnormal gastric emptying. We will also assess whether temporal changes in gastric electrical patterns, including with meal provocation, are correlated with temporal changes in symptoms.

Hypothesis:
We expect a subset of patients with functional dyspepsia, chronic nausea and vomiting syndrome, and gastroparesis will have gastric electrical abnormalities. Based on previous work, we expect to find an association of retrograde slow wave propagation with severity of patient symptoms. We also hypothesise that sustained patterns of abnormal slow wave propagation will lead to an increase in symptoms, in a manner that is temporally-correlated.

Confirming or disproving these hypotheses will also help to inform our ‘plausibility criteria’ work for determining whether or not gastric dysrhythmias are a disease mechanism for functional gastrointestinal disorders.

This work expands upon previous work (registered at https://classic.clinicaltrials.gov/ct2/show/NCT05812339)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122182 0
Dr Stefan Calder
Address 122182 0
Alimetry Ltd., 86 Symonds Street, Grafton,
Auckland, 1010, New Zealand
Country 122182 0
New Zealand
Phone 122182 0
+64 98708178
Fax 122182 0
Email 122182 0
stefan@alimetry.com
Contact person for public queries
Name 122183 0
Dr Stefan Calder
Address 122183 0
Alimetry Ltd., 86 Symonds Street, Grafton,
Auckland, 1010, New Zealand
Country 122183 0
New Zealand
Phone 122183 0
+64 98708178
Fax 122183 0
Email 122183 0
stefan@alimetry.com
Contact person for scientific queries
Name 122184 0
Dr Stefan Calder
Address 122184 0
Alimetry Ltd., 86 Symonds Street, Grafton,
Auckland, 1010, New Zealand
Country 122184 0
New Zealand
Phone 122184 0
+64 98708178
Fax 122184 0
Email 122184 0
stefan@alimetry.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and presented as aggregate statistics. No data that could potentially identify any individual participants will be published or distributed.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.