GastroparesisGPOEM-GEMSNCT06381349
Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
An observational study of Gastroparesis, run by Chris Varghese at 1 site in New Zealand.
Trial summary
Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric Alimetry test
- How many people
- 300 participants
- Where
- 1 siteNew Zealand
- Study dates
- 7 Jul 2024to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.
Who may be able to join
- Aged 18 years or older
- Indicated for GPOEM
Who cannot join
- Pregnant or breast-feeding
- Inability to perform Gastric Alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
University of Auckland
Auckland, Auckland, 1010
Chris Varghese, MBChB, +64 (0) 9 923 9820, cvar706@aucklanduni.ac.nz
About this study
Official title: Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted <1 month prior to GPOEM. All subjects will then be followed up for 12 months.
Read the detailed description
This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.
Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.
GPOEM will be performed as per standard site protocol, with data captured in RDCap.
Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.
Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.
- Conditions
- Gastroparesis
- Being tested
- Gastric Alimetry test
- Keywords
- endoscopy, electrophysiology, phenotyping
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Alimetry testDiagnostic test
Gastric Alimetry test will be performed within 30-days prior to G-POEM procedure. It's results will not inform clinical management in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with gastroparesis | 1. Provision of signed and dated informed consent form understand the risks and benefits of the study
2. Aged ≥18 years old
3. Patients must be clinically selected for GPOEM at their respective study site.
4. Patients are undergoing their index GPOEM procedure Receives: Diagnostic Test: Gastric Alimetry test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroparesis Cardinal Symptom Index (GCSI)
≥ 1 decrease in total GCSI score [higher score = worse symptoms]
Measured: 6 months
Secondary outcomes (9)
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)
0 - 5; higher score = better quality of life
Measured: 1, 3, 6, and 12 months
EQ-5D scores
0 - 1; higher score being better quality of life
Measured: 1, 3, 6, and 12 months
Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)
0 - 1; higher score being increased symptom burden
Measured: 1, 3, 6, and 12 months
Patient Health Questionnaire - 8 (PHQ-8)
0 - 12; higher score being increased depression severity
Measured: 6, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7)
0 - 21; higher score indicates increased anxiety
Measured: 6, and 12 months
Perceived Stress Scale 4 (PSS-4)
0 - 16; higher scores indicate higher stress
Measured: 6, and 12 months
Brief Illness Perception Questionnaire-Revised
0 - 80; higher scores indicate worse illness perception
Measured: 6, and 12 months
Alimetry® Gut-Brain Wellbeing (AGBW)
0 - 40; higher scores indicate higher mental health burden
Measured: 1, 3, 6, and 12 months
Work Productivity and Activity Impairment (WPAI)
0-100%; higher scores indicating increased loss of work productivity and activity impairment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start7 Jul 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Varghese
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chris Varghese, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381349
- Sponsor's protocol ID
- GPOEM-GEMS
- Acronym
- GPOEM-GEMS
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
- ClinicalTrials.gov ID
- NCT06381349
- Acronym / sponsor ID
- GPOEM-GEMS / GPOEM-GEMS
- Conditions
- Gastroparesis
- Keywords
- endoscopy, electrophysiology, phenotyping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chris VargheseUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Apr 2024 (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.
Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted <1 month prior to GPOEM. All subjects will then be followed up for 12 months.
Detailed description
This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.
Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.
GPOEM will be performed as per standard site protocol, with data captured in RDCap.
Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.
Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with gastroparesis | – | Diagnostic Test: Gastric Alimetry test1. Provision of signed and dated informed consent form understand the risks and benefits of the study 2. Aged ≥18 years old 3. Patients must be clinically selected for GPOEM at their respective study site. 4. Patients are undergoing their index GPOEM procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Indicated for GPOEM
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding
- Inability to perform Gastric Alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
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 Alimetry testGastric Alimetry test will be performed within 30-days prior to G-POEM procedure. It's results will not inform clinical management in this observational study. | Diagnostic test | Adult patients with gastroparesis |
Primary outcome
Gastroparesis Cardinal Symptom Index (GCSI)
Time frame: 6 months
≥ 1 decrease in total GCSI score [higher score = worse symptoms]
9 secondary outcomes
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)
Time frame: 1, 3, 6, and 12 months
EQ-5D scores
Time frame: 1, 3, 6, and 12 months
Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)
Time frame: 1, 3, 6, and 12 months
Patient Health Questionnaire - 8 (PHQ-8)
Time frame: 6, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: 6, and 12 months
Perceived Stress Scale 4 (PSS-4)
Time frame: 6, and 12 months
Brief Illness Perception Questionnaire-Revised
Time frame: 6, and 12 months
Alimetry® Gut-Brain Wellbeing (AGBW)
Time frame: 1, 3, 6, and 12 months
Work Productivity and Activity Impairment (WPAI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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. This study is not recruiting at the moment.
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 Gastroparesis, run by Chris Varghese 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 2 inclusion and 2 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 27 Mar 2025. 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?
Contact Chris Varghese, MBChB (+64 (0) 9 923 9820, cvar706@aucklanduni.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroparesis Cardinal Symptom Index (GCSI) (time frame: 6 months). 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 27 Mar 2025.