Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
NCT ID: NCT06381349
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-07-07
2026-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult patients with gastroparesis
1. Provision of signed and dated informed consent form understand the risks and benefits of the study
2. Aged ≥18 years old
3. Patients must be clinically selected for GPOEM at their respective study site.
4. Patients are undergoing their index GPOEM procedure
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Indicated for GPOEM
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Chris Varghese
OTHER
Responsible Party
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Chris Varghese
Lead Clinical Investigator
Locations
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University of Auckland
Auckland, Auckland, New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GPOEM-GEMS
Identifier Type: -
Identifier Source: org_study_id
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