Adults,Gastric Symptoms,Suspected Gastric Motility Disorders
Conditions
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
Detailed description
A prospective, non-randomised, single centre investigation on patients with suspected motility disorders comprising a simultaneous head-to-head comparison of device performance between the Gastric Alimetry System and the Medtronic Polygram NET / Polygraf ID EGG System.
Interventions
DEVICEGastric 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.
Sponsors
Greg O'Grady
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance comparison (frequency) between Gastric Alimetry and predicate device | 90 minutes | Mean frequency of raw data from predicate device compared with the same measure from the Gastric Alimetry System. Electrode placement is identical and recording is simultaneous. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance comparison (amplitude) between Gastric Alimetry and predicate device | 90 minutes | Mean amplitude of raw data from predicate device (4 electrodes) compared with the same measure from the Gastric Alimetry System (4 electrodes). Electrode placement is identical and recording is simultaneous. |
| Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes). | 90 minutes | Amplitude of raw data from Gastric Alimetry device (4 electrodes) compared with the same measure from the Gastric Alimetry System (8 electrodes with highest amplitude). Recording is simultaneous. |
| Safety Endpoint | Five hours | Safety endpoint: no unanticipated AEs or ADEs, and anticipated AEs and ADEs are acceptable relative to the risk acceptability criteria, as defined by the risk acceptability matrix (RSK-010). |
| User Needs Endpoint | Five hours | User needs validation results meet acceptability criteria. |
Countries
New Zealand
Outcome results
None listed