Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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 - 1. Provision of signed and dated informed consent form understand the risks and benefits of the study
2. Aged =18 years old
3. Patients must be clinically selected for GPOEM at their respective study site.
4. 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
Trial website
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

No information has been provided regarding IPD availability


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/NCT06381349