Non-invasive Measurement of Gastric Motility

NCT04992884 | Unknown

• 1 other identifier: CLD-014
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Adults,Gastric Symptoms,Suspected Gastric Motility Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Performance comparison (amplitude) between Gastric Alimetry and predicate device

  90 minutes

• Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).

  90 minutes

• Safety Endpoint

  Five hours

• User Needs Endpoint

  Five hours

Interventions

Gastric Alimetry DEVICE

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.

Also known as: Medtronic Polygram NET / Polygraf ID EGG system

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Greg O'Grady: lead

Study Sites (1)

Clinical Research Centre, Building 507, The University of Auckland

Auckland, 1023, New Zealand

Location

Study Officials

• John A Windsor

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 5, 2021
• Study Start: May 27, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

NZ (1)