Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
Chris Varghese
300 participants
Jul 7, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Aged 18 years or older
- Indicated for GPOEM
Exclusion Criteria2
- 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.
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Interventions
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(1)
View Full Details on ClinicalTrials.gov
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NCT06381349