Clinical trial NCT06381349: Predicting Outcomes of GPOEM Using Gastric Electrical Mapping
Official title: Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroparesis
Keywords: endoscopy
electrophysiology
phenotyping
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.

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.

Detailed description: This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.

Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.

GPOEM will be performed as per standard site protocol, with data captured in RDCap.

Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.

Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Indicated for GPOEM

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.

Primary outcomes:
measure: Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: 6 months
Secondary outcomes:
measure: Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)
timeFrame: 1, 3, 6, and 12 months
measure: EQ-5D scores
timeFrame: 1, 3, 6, and 12 months
measure: Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)
timeFrame: 1, 3, 6, and 12 months
measure: Patient Health Questionnaire - 8 (PHQ-8)
timeFrame: 6, and 12 months
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: 6, and 12 months
measure: Perceived Stress Scale 4 (PSS-4)
timeFrame: 6, and 12 months
measure: Brief Illness Perception Questionnaire-Revised
timeFrame: 6, and 12 months
measure: Alimetry® Gut-Brain Wellbeing (AGBW)
timeFrame: 1, 3, 6, and 12 months
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: 12 months
Other outcomes:
measure: Change in Gastric Alimetry Phenotype
timeFrame: 6
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
References: