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

NCT06854120 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2025-03-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Western Sydney

    collaborator OTHER

  • Temple University

    collaborator OTHER

  • North Shore Hospital, New Zealand

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Henry Parkman, MD · Temple University

  • Vincent Ho, MBBS, FRACP, FACP, PhD · University of Western Sydney

  • Charlotte Daker, MD · University of Auckland, New Zealand

  • Greg O'Grady, MD, PhD · University of Auckland, New Zealand

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2028-02-26
Completion
2028-08-26
FDA Device
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854120 on ClinicalTrials.gov