NCT06854120

Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects

Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: University of Auckland, New Zealand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.

Conditions

• Gastroparesis
• Functional Dyspepsia

Interventions

Type	Name	Description
DEVICE	Gastric Alimetry	The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Timeline

• Start date: 2025-02-26
• Primary completion: 2028-02-26
• Completion: 2028-08-26
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

3 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study