Comparing two methods for diagnosing gastroparesis
Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
NA · University of Western Sydney · NCT06411574
This study is testing a new non-invasive method called body surface gastric mapping to see if it can diagnose gastroparesis better than the traditional gastric emptying test for adults with this condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Western Sydney (other) |
| Locations | 1 site (Campbelltown, New South Wales) |
| Trial ID | NCT06411574 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of body surface gastric mapping (BSGM) compared to gastric emptying scintigraphy (GES) in managing gastroparesis, a condition characterized by delayed gastric emptying. The study aims to determine if BSGM, a non-invasive method using a new FDA-cleared device, can provide better diagnostic insights and guide personalized treatment strategies. Participants will be adults over 18 who meet specific criteria and have been referred for GES. The trial seeks to address the limitations of current diagnostic methods and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who meet the Rome IV criteria for functional dyspepsia or chronic nausea and vomiting syndrome and have been referred for gastric emptying scintigraphy.
Not a fit: Patients who are pregnant, breastfeeding, or have severe skin allergies or conditions that prevent them from undergoing the BSGM test will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored therapies for patients suffering from gastroparesis.
How similar studies have performed: While gastric emptying scintigraphy is the current gold standard, the use of body surface gastric mapping is a novel approach that has not been widely tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged over 18 years old * Meeting Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome * Referred for gastric emptying scintigraphy * Normal gastroscopy * Negative or treated H. Pylori status Exclusion Criteria: * Pregnant or breast-feeding * Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.
Where this trial is running
Campbelltown, New South Wales
- Western Sydney University — Campbelltown, New South Wales, Australia (RECRUITING)
Study contacts
- Principal investigator: Vincent Ho, MBBS, FRACP, FACP, PhD — Western Sydney University
- Study coordinator: Daphne Foong, PhD
- Email: d.foong@westernsydney.edu.au
- Phone: +61 2 4634 4579
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.
Conditions: Gastroparesis, Motility Disorders, Gastric Emptying Scintigraphy, Body Surface Gastric Mapping