An observational study in Gastroparesis, sponsored by Chris Varghese. Recruiting at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Chris Varghese · Observational
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.
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.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 77 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →This is the only study on the registry with Chris Varghese as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.
Exclusion Criteria:
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
Diagnostic Test: Gastric Alimetry 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.
Gastroparesis Cardinal Symptom Index (GCSI)
≥ 1 decrease in total GCSI score \[higher score = worse symptoms\]
Time frame: 6 months
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)
0 - 5; higher score = better quality of life
Time frame: 1, 3, 6, and 12 months
EQ-5D scores
0 - 1; higher score being better quality of life
Time frame: 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
Time frame: 1, 3, 6, and 12 months
Patient Health Questionnaire - 8 (PHQ-8)
0 - 12; higher score being increased depression severity
Time frame: 6, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7)
0 - 21; higher score indicates increased anxiety
Time frame: 6, and 12 months
Perceived Stress Scale 4 (PSS-4)
0 - 16; higher scores indicate higher stress
Time frame: 6, and 12 months
Brief Illness Perception Questionnaire-Revised
0 - 80; higher scores indicate worse illness perception
Time frame: 6, and 12 months
Alimetry® Gut-Brain Wellbeing (AGBW)
0 - 40; higher scores indicate higher mental health burden
Time frame: 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
Time frame: 12 months
Change in Gastric Alimetry Phenotype
Change in phenotype classification on repeat Gastric Alimetry testing before and after G-POEM
Time frame: 6
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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