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RECRUITING
NCT06283381
PHASE4

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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

Official title: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-02-01

Completion Date

2026-06-30

Last Updated

2024-02-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Esomeprazole

oral administration, tablets, 40 mg

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy