Gastric 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/37782524/Actively Recruiting
Led by University of Western Sydney · Updated on 2025-02-27
40
Participants Needed
1
Research Sites
61 weeks
Total Duration
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
Body Surface Gastric Mapping Vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis
D
Daphne Foong, PhD
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University of Western Sydney
Lead Sponsor
University of Auckland, New Zealand
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo gastric emptying scintigraphy and body surface gastric mapping tests to assist in diagnosing gastroparesis.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/36534985/University of Western Sydney
Lead Sponsor
University of Auckland, New Zealand
Collaborating Sponsor