Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device.
Armen A Gharibans, Stefan Calder, Chris Varghese...
https://pubmed.ncbi.nlm.nih.gov/36130019Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06411574
Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
Led by University of Western Sydney · Updated on 2025-02-27
40
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
U
University of Western Sydney
Lead Sponsor
U
University of Auckland, New Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gastroparesis is a chronic stomach condition that causes persistent upper gastrointestinal symptoms and delayed stomach emptying without any physical blockage. It often leads to poor quality of life, psychological distress, frequent hospital visits, and high healthcare costs. Current diagnosis mainly relies on gastric emptying scintigraphy (GES), but its usefulness is being questioned. There is a need for better diagnostic tools to understand the disease and guide personalized treatment. This study is testing a new device called Gastric Alimetry, which uses body surface gastric mapping (BSGM) to non-invasively measure stomach movements and symptoms. The trial has two phases: Phase 1 involves patients undergoing both GES and BSGM tests, with doctors making treatment plans based either on GES alone or both GES and BSGM results. In Phase 2, patients receive care guided by the combined test results for 12 months. Another group will receive standard care based on GES only, then switch to BSGM-guided care after 12 months and be followed for 6 months. Participants will complete questionnaires assessing symptoms, quality of life, mental health, sleep, and work impact throughout the study. Researchers will compare how treatment decisions change based on test results and assess healthcare use and costs over time. The goal is to see if BSGM-guided care can improve management of gastroparesis and reduce the need for invasive or radioactive diagnostic procedures.
CONDITIONS
Brief Title
Body Surface Gastric Mapping Vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged over 18 years old
- Meet Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome
- Referred for gastric emptying scintigraphy
- Have had a normal gastroscopy
- Have a negative or treated Helicobacter pylori infection status
You will not qualify if you...
- Currently pregnant or breastfeeding
- Unable to perform a body surface gastric mapping test due to severe skin allergies or sensitivity to cosmetics or lotions
- Have chronically damaged or vulnerable skin on the upper belly area such as fragile skin, wounds, or inflammation
- Unable to remain in a relaxed reclined position for the test duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo gastric emptying scintigraphy and body surface gastric mapping tests to assist in diagnosing gastroparesis.
1 visit (in-person)
Long-term Monitoring
Duration - 12 months
Participants are monitored for up to 12 months to assess changes in clinical management and healthcare utilization based on test results.
Periodic assessments during the 12 months
Trial Site Locations
Total: 1 location
1
Western Sydney University
Campbelltown, New South Wales, Australia, 2560
Actively Recruiting
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Research Team
D
Daphne Foong, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis.
Chris Varghese, Gabriel Schamberg, Stefan Calder...
https://pubmed.ncbi.nlm.nih.gov/36534985Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy.
William Jiaen Wang, Daphne Foong, Stefan Calder...
https://pubmed.ncbi.nlm.nih.gov/37782524Gastric Alimetry in the Management of Chronic Gastroduodenal Disorders: Impact to Diagnosis and Health Care Utilization.
Chris Varghese, Charlotte Daker, Alexandria Lim...
https://pubmed.ncbi.nlm.nih.gov/37589479Defining and Phenotyping Gastric Abnormalities in Long-Term Type 1 Diabetes Using a Novel Body Surface Gastric Mapping Device.
William Xu, Armen A Gharibans, Stefan Calder...
https://pubmed.ncbi.nlm.nih.gov/39131562Characterization of gastric dysfunction after fundoplication using body surface gastric mapping.
William Xu, Tim Wang, Daphne Foong...
https://pubmed.ncbi.nlm.nih.gov/38445915