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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06411574




Registration number
NCT06411574
Ethics application status
Date submitted
28/04/2024
Date registered
13/05/2024

Titles & IDs
Public title
Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis
Scientific title
Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
Secondary ID [1] 0 0
WS-GMSC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Gastric Alimetry

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in clinical management decisions based on the combined test results.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Healthcare utilization (expressed as work impairment percentages; higher scores meaning worse outcome) between standard of care and BSGM-guided care.
Timepoint [2] 0 0
12 months.
Primary outcome [3] 0 0
Healthcare utilization-associated costs (expressed as the total amount in AUD) between standard of care and BSGM-guided care.
Timepoint [3] 0 0
12 months.
Secondary outcome [1] 0 0
Change in clinical management decisions based on order of unblinding motility test results (GES then BSGM vs BSGM then GES).
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
12 months.
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
12 months.
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
12 months.
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
12 months.
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
12 months.
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
12 months.
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Campbelltown
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Western Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Auckland, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vincent Ho, MBBS, FRACP, FACP, PhD
Address 0 0
Western Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daphne Foong, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 4634 4579
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06411574