Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis

May 7, 2024 updated by: Vincent Ho, University of Western Sydney

Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis

Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy.

Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain.

This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact.

If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged over 18 years old
  • Meeting Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome
  • Referred for gastric emptying scintigraphy
  • Normal gastroscopy
  • Negative or treated H. Pylori status

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Only the GES test result will be used to guide treatment as part of standard of care.
Experimental: BSGM-guided care
Both the GES and BSGM test results will be used to guide treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical management decisions based on the combined test results.
Time Frame: Baseline
A change constitutes any change within a category (e.g. from a prokinetic to neuromodulator, from one prokinetic to another), addition of category or removal of category. If the plan remains the same, this is considered no change.
Baseline
Healthcare utilization (expressed as work impairment percentages; higher scores meaning worse outcome) between standard of care and BSGM-guided care.
Time Frame: 12 months.
Work impairment scale is Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (minimum: 0; maximum: 100).
12 months.
Healthcare utilization-associated costs (expressed as the total amount in AUD) between standard of care and BSGM-guided care.
Time Frame: 12 months.
Costs associated with healthcare events (emergency department visits, hospital admissions, gastroenterology clinic visits and investigations) before and after testing.
12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical management decisions based on order of unblinding motility test results (GES then BSGM vs BSGM then GES).
Time Frame: Baseline
A change constitutes any change within a category (e.g. from a prokinetic to neuromodulator, from one prokinetic to another), addition of category or removal of category. If the plan remains the same, this is considered no change. The change will then be compared between unblinding GES then BSGM vs BSGM then GES.
Baseline
Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a lower score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores between standard of care and BSGM-guided care (with a lower score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in Patient Health Questionnaire-8 (minimum: 0; maximum: 24) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).
Time Frame: 12 months.
12 months.
Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).
Time Frame: 12 months.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Sydney

Collaborators

University of Auckland, New Zealand

Investigators

  • Principal Investigator: Vincent Ho, MBBS, FRACP, FACP, PhD, Western Sydney University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 3, 2024

Primary Completion (Estimated)

May 3, 2025

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS-GMSC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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