Predicting Outcomes of GPOEM Using Gastric Electrical Mapping (GPOEM-GEMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Diagnostic test: Gastric Alimetry test

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Chris Varghese, MBChB; Phone Number: +64 (0) 9 923 9820; Email: cvar706@aucklanduni.ac.nz

Study Locations

• New Zealand
  • Auckland, New Zealand, 1010
    • Recruiting
    • University of Auckland
    • Contact: Chris Varghese, MBChB; Phone Number: +64 (0) 9 923 9820; Email: cvar706@aucklanduni.ac.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.

Description

Inclusion Criteria:

• Aged 18 years or older
• Indicated for GPOEM

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with gastroparesis; Provision of signed and dated informed consent form understand the risks and benefits of the study; Aged ≥18 years old; Patients must be clinically selected for GPOEM at their respective study site.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroparesis Cardinal Symptom Index (GCSI)	≥ 1 decrease in total GCSI score [higher score = worse symptoms]	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)	0 - 5; higher score = better quality of life	1, 3, 6, and 12 months
EQ-5D scores	0 - 1; higher score being better quality of life	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	1, 3, 6, and 12 months
Alimetry® Gut-Brain Wellbeing (AGBW)	0 - 40; higher scores indicate higher mental health burden	1, 3, 6, and 12 months
Patient Health Questionnaire - 8 (PHQ-8)	0 - 12; higher score being increased depression severity	6, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7)	0 - 21; higher score indicates increased anxiety	6, and 12 months
Perceived Stress Scale 4 (PSS-4)	0 - 16; higher scores indicate higher stress	6, and 12 months
Brief Illness Perception Questionnaire-Revised	0 - 80; higher scores indicate worse illness perception	6, and 12 months
Work Productivity and Activity Impairment (WPAI)	0-100%; higher scores indicating increased loss of work productivity and activity impairment	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastric Alimetry Phenotype	Change in phenotype classification on repeat Gastric Alimetry testing before and after G-POEM	6

Collaborators and Investigators

• Sponsor: Chris Varghese

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: endoscopy; electrophysiology; phenotyping
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: GPOEM-GEMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No