Predicting outcomes of a gastric procedure using electrical mapping
Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
This study is testing if a new method called Gastric Alimetry can help predict how well a gastric procedure will work for people with gastroparesis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Auckland, New Zealand Academic / other |
| Locations | 1 site (Auckland, Auckland) |
| Trial ID | NCT06381349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Gastric Alimetry in predicting the outcomes of gastric peroral endoscopic myotomy (GPOEM) for patients with gastroparesis. Participants will undergo a baseline Gastric Alimetry assessment and will be followed for 12 months post-procedure to evaluate their symptoms, quality of life, and health psychology. The study seeks to develop a clinical decision rule to improve patient selection for GPOEM. Data will be collected through standard protocols and follow-up assessments using the myCap app.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are indicated for GPOEM.
Not a fit: Patients who are pregnant, breastfeeding, or unable to perform the Gastric Alimetry test due to skin sensitivities or other health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the selection process for GPOEM, leading to improved treatment outcomes for patients with gastroparesis.
How similar studies have performed: While the approach of using Gastric Alimetry is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Indicated for GPOEM Exclusion Criteria: * 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.
Where this trial is running
Auckland, Auckland
- University of Auckland — Auckland, Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Chris Varghese, MBChB
- Email: cvar706@aucklanduni.ac.nz
- Phone: +64 (0) 9 923 9820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.