Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

Last updated: March 24, 2025
Sponsor: Chris Varghese
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Treatment

Gastric Alimetry test

Clinical Study ID

NCT06381349
GPOEM-GEMS
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older

  • Indicated for GPOEM

Exclusion

Exclusion Criteria:

  • Pregnant or breast-feeding

  • Inability to perform Gastric Alimetry test: history of severe skin allergies orsensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastricskin (fragile skin, wounds, inflammation); patients unable to remain in a relaxedreclined position for the test duration.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Gastric Alimetry test
Phase:
Study Start date:
July 07, 2024
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • University of Auckland

    Auckland, 1010
    New Zealand

    Active - Recruiting

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