Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged 18 years or older
• Indicated for GPOEM
Locations
Other Locations
New Zealand
University of Auckland
RECRUITING
Auckland
Contact Information
Primary
Chris Varghese, MBChB
cvar706@aucklanduni.ac.nz
+64 (0) 9 923 9820
Time Frame
Start Date: 2024-07-07
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 300
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Chris Varghese