GastroparesisNCT06854120
Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects
An observational study of Gastroparesis and Functional Dyspepsia, run by University of Auckland, New Zealand at 3 sites in 3 countries.
Trial summary
Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Functional Dyspepsia
- What is being tested?
- Gastric Alimetry
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Feb 2025to 26 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.
Who may be able to join
- Patients 18 years of age and older
- Diagnosis of gastroparesis and/or functional dyspepsia
- Being prescribed a prokinetic agent or symptom modulator for their clinical care
- Able to undergo BSGM recording both before and during treatment
- Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment
Who cannot join
- Under 18 years of age
- Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
- Pregnant women
- No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Not yet recruiting
Temple University
Philadelphia, Pennsylvania, 19122
Henry Parkman, PhD/MD, 800-836-7536, henry.parkman@temple.edu
Henry Parkman, MD, PhD
Australia1 site, 1 recruiting
- Recruiting
Western Sydney University
Sydney, New South Wales, 2560
Madhuri Venigalla, PhD, +61 2 4634 4579, madhuri.venigalla@alimetry.com
Vincent Ho, MBBS, FRACP, FACP, PhD
New Zealand1 site, 1 recruiting
- Recruiting
Te Whatu Ora Waitemata
Auckland, Auckland, 0622
Charlotte Daker, MD, +64 21 349 305, Charlotte.Daker@waitematadhb.govt.nz
Charlotte Daker, MD
About this study
Official title: Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy
Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.
- Conditions
- Gastroparesis, Functional Dyspepsia
- Being tested
- Gastric Alimetry
- Keywords
- Gastroparesis, Functional Dyspepsia, Gastric Motility, Body Surface Gastric Mapping
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric AlimetryDevice
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator Receives: Device: Gastric Alimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).
Measured: 8 weeks
Secondary outcomes (3)
Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).
Measured: 8 weeks
Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).
Measured: 8 weeks
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start26 Feb 2025
- Primary completion26 Feb 2028 (estimated)
- Study completion26 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies 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
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Sydney, Temple University, North Shore Hospital, New Zealand
- Responsible party
- Principal investigator, Greg O'Grady, University of Auckland, New Zealand
- Investigators
- Henry Parkman, MD, Principal investigator, Temple UniversityVincent Ho, MBBS, FRACP, FACP, PhD, Principal investigator, University of Western SydneyCharlotte Daker, MD, Principal investigator, University of Auckland, New ZealandGreg O'Grady, MD, PhD, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854120
- Sponsor's protocol ID
- AK-PRO-001
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study design means that no identifiable data will be shared beyond immediate study researchers at each location.
Publications
Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
PubMed 36534985Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
PubMed 37782524Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
PubMed 36130019
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy
- ClinicalTrials.gov ID
- NCT06854120
- Acronym / sponsor ID
- AK-PRO-001
- Conditions
- Gastroparesis, Functional Dyspepsia
- Keywords
- Gastroparesis, Functional Dyspepsia, Gastric Motility, Body Surface Gastric Mapping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- University of Western Sydney, Temple University, North Shore Hospital, New Zealand
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 26 Feb 2028 (estimated)
- Study completion
- 26 Aug 2028 (estimated)
- First posted
- 3 Mar 2025 (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.
Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Gastric AlimetryPatients undergoing Body Surface Gastric Mapping before and after administration of prescribed prokinetic/neuromodulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gastroparesis and/or functional dyspepsia who are prescribed prokinetics/neuromodulators.
Key inclusion criteria (5 listed)
- Patients 18 years of age and older
- Diagnosis of gastroparesis and/or functional dyspepsia
- Being prescribed a prokinetic agent or symptom modulator for their clinical care
- Able to undergo BSGM recording both before and during treatment
- Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment
Key exclusion criteria (5 listed)
- Under 18 years of age
- Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
- Pregnant women
- No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved
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 AlimetryThe Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. | Device | Treatment |
Primary outcome
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).
Time frame: 8 weeks
3 secondary outcomes
Change in overall BSGM BMI-Adjusted Amplitude on treatment compared to baseline (normal range: 22-70 μV).
Time frame: 8 weeks
Change in overall BSGM Principal Gastric Frequency (minimum: 0; maximum: 5) on treatment compared to baseline (normal range: 2.65-3.35 cpm).
Time frame: 8 weeks
Change in overall BSGM Fed:Fasted Amplitude Ratio on treatment compared to baseline (normal range: >1.08).
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 36534985Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
- Background: PubMed 37782524Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
- Background: PubMed 36130019Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
- Individual participant dataSharing planned: No. The study design means that no identifiable data will be shared beyond immediate study researchers at each location.
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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.
Henry Parkman, MD principal investigator
Temple University
Vincent Ho, MBBS, FRACP, FACP, PhD principal investigator
University of Western Sydney
Charlotte Daker, MD principal investigator
University of Auckland, New Zealand
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Functional Dyspepsia, run by University of Auckland, New Zealand at 3 sites in 3 countries.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genevieve M Johnston, PhD (+64 9 373 7599, gen.johnston@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854120, which also lists 3 linked publications.
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 11 Jun 2026.