Adults,Gastric Symptoms,Suspected Gastric Motility DisordersNCT04992884
Non-invasive Measurement of Gastric Motility
An observational study of Adults,Gastric Symptoms,Suspected Gastric Motility Disorders, run by Greg O'Grady at 1 site in New Zealand.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Adults,Gastric Symptoms,Suspected Gastric Motility Disorders
- What is being tested?
- Gastric Alimetry
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteNew Zealand
- Study dates
- 27 May 2021to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 adult patients with upper gastrointestinal symptoms suspected to have gastric motility disorders.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Clinical Research Centre, Building 507, The University of Auckland
Auckland, 1023
About this study
Official title: 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
Read the 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.
- Being tested
- Gastric Alimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric AlimetryDevice
Also called Medtronic Polygram NET / Polygraf ID EGG system
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: Five hours
User Needs Endpoint
User needs validation results meet acceptability criteria.
Measured: Five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start27 May 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults,Gastric Symptoms,Suspected Gastric Motility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg O'Grady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Greg O'Grady, University of Auckland, New Zealand
- Investigators
- John A Windsor, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992884
- Sponsor's protocol ID
- CLD-014
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
- ClinicalTrials.gov ID
- NCT04992884
- Acronym / sponsor ID
- CLD-014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Greg O'GradyUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 adult patients with upper gastrointestinal symptoms suspected to have gastric motility disorders.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric AlimetryAlso: Medtronic Polygram NET / Polygraf ID EGG systemGastric 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. | Device | – |
Primary outcome
Performance comparison (frequency) between Gastric Alimetry and predicate device
Time frame: 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.
4 secondary outcomes
Performance comparison (amplitude) between Gastric Alimetry and predicate device
Time frame: 90 minutes
Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).
Time frame: 90 minutes
Safety Endpoint
Time frame: Five hours
User Needs Endpoint
Time frame: Five hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Windsor principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults,Gastric Symptoms,Suspected Gastric Motility Disorders, run by Greg O'Grady at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance comparison (frequency) between Gastric Alimetry and predicate device (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.