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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
Date last updated
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
Not applicable
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
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.
Trial website
https://clinicaltrials.gov/study/NCT06411574
Trial related presentations / publications
Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
Varghese C, Daker C, Lim A, Sebaratnam G, Xu W, Kean B, Cederwall C. Gastric Alimetry in the Management of Chronic Gastroduodenal Disorders: Impact to Diagnosis and Health Care Utilization. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00626. doi: 10.14309/ctg.0000000000000626.
Varghese C, Xu W, Daker C, Bissett IP, Cederwall C. Clinical utility of Gastric Alimetry® in the management of intestinal failure patients with possible underlying gut motility disorders. Clinical Nutrition Open Science [Internet]. 2023 Oct 1;51:15-25. Available from: https://www.sciencedirect.com/science/article/pii/S2667268523000359.
Xu W, Gharibans AA, Calder S, Schamberg G, Walters A, Jang J, et al. Defining and phenotyping gastric abnormalities in long-term type 1 diabetes using a novel body surface gastric mapping device. Gastro Hep Adv [Internet]. 2023 Aug; Available from: http://dx.doi.org/10.1016/j.gastha.2023.08.005
Xu W, Wang T, Foong D, Schamberg G, Evennett N, Beban G, Gharibans A, Calder S, Daker C, Ho V, O'Grady G. Characterization of gastric dysfunction after fundoplication using body surface gastric mapping. J Gastrointest Surg. 2024 Mar;28(3):236-245. doi: 10.1016/j.gassur.2023.12.023. Epub 2024 Jan 23.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06411574