Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04992884




Registration number
NCT04992884
Ethics application status
Date submitted
14/07/2021
Date registered
5/08/2021
Date last updated
19/10/2021

Titles & IDs
Public title
Non-invasive Measurement of Gastric Motility
Scientific title
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Secondary ID [1] 0 0
CLD-014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults,Gastric Symptoms,Suspected Gastric Motility Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Gastric Alimetry

Treatment: Devices: Gastric Alimetry
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance comparison (frequency) between Gastric Alimetry and predicate device
Timepoint [1] 0 0
90 minutes
Secondary outcome [1] 0 0
Performance comparison (amplitude) between Gastric Alimetry and predicate device
Timepoint [1] 0 0
90 minutes
Secondary outcome [2] 0 0
Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).
Timepoint [2] 0 0
90 minutes
Secondary outcome [3] 0 0
Safety Endpoint
Timepoint [3] 0 0
Five hours
Secondary outcome [4] 0 0
User Needs Endpoint
Timepoint [4] 0 0
Five hours

Eligibility
Key inclusion criteria
- Age 22 years old or older

- Able to provide written informed consent

- Patients with a suspected motility disorder, meetingRome IVCriteria for functional
dyspepsia or chronic nausea and vomiting syndromes or having a diagnosis of
gastroparesis as confirmed by a standardized gastric scintigraphy study, including
having >10% gastric meal retention at 4-hours.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- BMI >35 kg m(2)

- Known metabolic, neurogenic or endocrine disorders known to cause gastrointestinal
dysmotility e.g. multiple sclerosis, Parkinson's disease, hypothyroidism

- Known current gastrointestinal infection (includes H.pylori when being actively
treated)

- Known current inflammatory bowel disease

- Known current gastrointestinal malignancy

- Previous gastroduodenal surgery

- Open abdominal wounds or abdominal skin not intact (e.g.rash, abrasions, weeping
tissues)

- Fragile skin evidenced by high susceptibility to skin tears or skin that bruises
easily

- Regular cannabis use

- Allergy to adhesives

- Pregnancy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2021
Actual
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Greg O'Grady
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Clinical evaluation to compare performance of the physiological recordings from the Gastric
Alimetry System vs a predicate reference device (Medtronic Polygram NET / Polygraf ID EGG
System
Trial website
https://clinicaltrials.gov/ct2/show/NCT04992884
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John A Windsor
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04992884