Predicting Outcomes of GPOEM Using Gastric Electrical Mapping

NCT06381349 | Recruiting FDA Device

• 1 other identifier: GPOEM-GEMS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

endoscopy; electrophysiology; phenotyping

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom Index (GCSI)

  ≥ 1 decrease in total GCSI score \[higher score = worse symptoms\]

  6 months

Secondary Outcomes (9)

• Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)

  1, 3, 6, and 12 months

• EQ-5D scores

  1, 3, 6, and 12 months

• Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)

  1, 3, 6, and 12 months

• Patient Health Questionnaire - 8 (PHQ-8)

  6, and 12 months

• Generalized Anxiety Disorder 7-item (GAD-7)

  6, and 12 months

Other Outcomes (1)

• Change in Gastric Alimetry Phenotype

  6

Study Arms (1)

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

Diagnostic Test: Gastric Alimetry test

Interventions

Gastric Alimetry test DIAGNOSTIC_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.

Adult patients with gastroparesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or older
• Indicated for GPOEM

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chris Varghese: lead

Study Sites (1)

University of Auckland

Auckland, Auckland, 1010, New Zealand

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chris Varghese, MBChB

CONTACT

+64 (0) 9 923 9820; cvar706@aucklanduni.ac.nz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Clinical Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: July 7, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2024-05

Locations

NZ (1)