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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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30 adult patients with upper gastrointestinal symptoms suspected to have gastric motility disorders.
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| Name | Affiliation | Role |
|---|---|---|
| John A Windsor | University of Auckland, New Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre, Building 507, The University of Auckland | Auckland | 1023 | New Zealand |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 26, 2022 | |
| Reset | Mar 28, 2022 | |
| Release | Jul 4, 2022 | |
| Reset | May 4, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 26, 2022 | Mar 28, 2022 | |||
| Jul 4, 2022 |
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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 |
| May 4, 2023 |