Non-invasive Measurement of Gastric Motility

NCT ID: NCT04992884

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Adults,Gastric Symptoms,Suspected Gastric Motility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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 Type DEVICE

Other Intervention Names

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Medtronic Polygram NET / Polygraf ID EGG system

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greg O'Grady

OTHER

Sponsor Role lead

Responsible Party

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Greg O'Grady

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John A Windsor

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

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Clinical Research Centre, Building 507, The University of Auckland

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CLD-014

Identifier Type: -

Identifier Source: org_study_id