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Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

NCT06381349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-03-27

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Chris Varghese

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-07
Primary Completion
2026-05-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381349 on ClinicalTrials.gov