Non-invasive Measurement of Gastric Motility

• Conditions: Adults,Gastric Symptoms,Suspected Gastric Motility Disorders

• Registration Number: NCT04992884
• Lead Sponsor: Greg O'Grady

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.

Study Timeline

• Study Start: 2021-05-27
• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-17
• Last Update Posted: 2021-10-19
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Research Centre, Building 507, The University of Auckland; 🇳🇿 Auckland, New Zealand