drugset / Trial / NCT06283381

The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

NCT06283381

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms: * Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure. * Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment). The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG

Timeline

Start
2024-02-01
Primary completion
2025-01-31
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 40 mg Oral

Indications