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RECRUITING
NCT06381349

Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Sponsor: Chris Varghese

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2024-07-07

Completion Date

2026-06-01

Last Updated

2025-03-27

Healthy Volunteers

No

Conditions

Interventions

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 (1)

University of Auckland

Auckland, Auckland, New Zealand