Predicting Outcomes of GPOEM Using Gastric Electrical Mapping (GPOEM-GEMS)

Chris Varghese

Status: Enrolling

Conditions: Gastroparesis

Treatments: Diagnostic Test: Gastric Alimetry test

Study type: Observational

Funder types: Other

Identifiers

NCT06381349

GPOEM-GEMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Adult patients with gastroparesis

Description:

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

Treatment:

Diagnostic Test: Gastric Alimetry test