This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia
Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
University of California Los Angeles
Los Angeles, California, United States
Frequency of Contractions at Baseline
Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).
Time frame: Comparison between stomach contractions at baseline (Stage 1/ before sham meal)
Largest Diameter of the Pylorus
Physiologic parameter measuring the diameter of the pylorus
Time frame: assessed after the sham meal (stage II, completed within 2 hours of baseline)
Dyspepsia Severity Scale Symptom Ratings at Baseline.
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20; with higher scores indicating more severe symptoms of dyspepsia) at baseline.
Time frame: Assessed at baseline.
Number of Participants With Procedure Related Adverse Events
Procedure related adverse events during or after the study session
Time frame: Through participants' study participation, approximately 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.