Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Gastroparesis Clinical Trial

— GPOEM-GEMS  

Official title:

Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381349
• Other study ID #: GPOEM-GEMS
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: University of Auckland, New Zealand
• Contact: Chris Varghese, MBChB
• Phone: +64 (0) 9 923 9820
• Email: cvar706[@]aucklanduni.ac.nz
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

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.

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Chris Varghese

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Gastric Alimetry Phenotype	Change in phenotype classification on repeat Gastric Alimetry testing before and after G-POEM	6
Primary	Gastroparesis Cardinal Symptom Index (GCSI)	= 1 decrease in total GCSI score [higher score = worse symptoms]	6 months
Secondary	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
Secondary	EQ-5D scores	0 - 1; higher score being better quality of life	1, 3, 6, and 12 months
Secondary	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
Secondary	Patient Health Questionnaire - 8 (PHQ-8)	0 - 12; higher score being increased depression severity	6, and 12 months
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	0 - 21; higher score indicates increased anxiety	6, and 12 months
Secondary	Perceived Stress Scale 4 (PSS-4)	0 - 16; higher scores indicate higher stress	6, and 12 months
Secondary	Brief Illness Perception Questionnaire-Revised	0 - 80; higher scores indicate worse illness perception	6, and 12 months
Secondary	Alimetry® Gut-Brain Wellbeing (AGBW)	0 - 40; higher scores indicate higher mental health burden	1, 3, 6, and 12 months
Secondary	Work Productivity and Activity Impairment (WPAI)	0-100%; higher scores indicating increased loss of work productivity and activity impairment	12 months