Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06381349




Registration number
NCT06381349
Ethics application status
Date submitted
15/04/2024
Date registered
24/04/2024
Date last updated
31/05/2024

Titles & IDs
Public title
Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
Scientific title
Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
Secondary ID [1] 0 0
GPOEM-GEMS
Universal Trial Number (UTN)
Trial acronym
GPOEM-GEMS
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Gastric Alimetry test

Adult patients with gastroparesis - Provision of signed and dated informed consent form understand the risks and benefits of the study
Aged =18 years old
Patients must be clinically selected for GPOEM at their respective study site.
Patients are undergoing their index GPOEM procedure


Diagnosis / Prognosis: Gastric Alimetry test
Gastric Alimetry test will be performed within 30-days prior to G-POEM procedure. It's results will not inform clinical management in this observational study.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gastroparesis Cardinal Symptom Index (GCSI)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)
Timepoint [1] 0 0
1, 3, 6, and 12 months
Secondary outcome [2] 0 0
EQ-5D scores
Timepoint [2] 0 0
1, 3, 6, and 12 months
Secondary outcome [3] 0 0
Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)
Timepoint [3] 0 0
1, 3, 6, and 12 months
Secondary outcome [4] 0 0
Patient Health Questionnaire - 8 (PHQ-8)
Timepoint [4] 0 0
6, and 12 months
Secondary outcome [5] 0 0
Generalized Anxiety Disorder 7-item (GAD-7)
Timepoint [5] 0 0
6, and 12 months
Secondary outcome [6] 0 0
Perceived Stress Scale 4 (PSS-4)
Timepoint [6] 0 0
6, and 12 months
Secondary outcome [7] 0 0
Brief Illness Perception Questionnaire-Revised
Timepoint [7] 0 0
6, and 12 months
Secondary outcome [8] 0 0
Alimetry® Gut-Brain Wellbeing (AGBW)
Timepoint [8] 0 0
1, 3, 6, and 12 months
Secondary outcome [9] 0 0
Work Productivity and Activity Impairment (WPAI)
Timepoint [9] 0 0
12 months

Eligibility
Key inclusion criteria
- Aged 18 years or older

- Indicated for GPOEM
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 Gastric Alimetry test: history of severe skin allergies or
sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin
(fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined
position for the test duration.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Chris Varghese
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves
dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a
single-arm, multi-centre, prospective observational study to determine the clinical utility
of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to
develop a clinical decision rule to inform patient selection. Gastric Alimetry will be
conducted <1 month prior to GPOEM. All subjects will then be followed up for 12 months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06381349
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chris Varghese, MBChB
Address 0 0
Country 0 0
Phone 0 0
+64 (0) 9 923 9820
Fax 0 0
Email 0 0
cvar706@aucklanduni.ac.nz
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06381349