Non-invasive Measurement of Gastric Motility

Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adults,Gastric Symptoms,Suspected Gastric Motility Disorders
• Intervention / Treatment: Device: Gastric Alimetry

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Clinical Research Centre, Building 507, The University of Auckland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 adult patients with upper gastrointestinal symptoms suspected to have gastric motility disorders.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance comparison (frequency) between Gastric Alimetry and predicate device	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.	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance comparison (amplitude) between Gastric Alimetry and predicate device	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.	90 minutes
Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).	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.	90 minutes
Safety Endpoint	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).	Five hours
User Needs Endpoint	User needs validation results meet acceptability criteria.	Five hours

Collaborators and Investigators

• Sponsor: Greg O'Grady
• Investigators: Principal Investigator: John A Windsor, University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CLD-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No