Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283381
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Brief Title:
The ESG Integrity Study Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESGIS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None