Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319924
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-02-28
Brief Title:
Fixed Low-dose Simethicone Combined With Macrogol 4000 PEG Reduces Colon Bubble Formation in Colonoscopy
Sponsor:
Hospital St Joseph Marseille France
Organization:
Hospital St Joseph Marseille France
Study Overview
Official Title:
Fixed Low-dose Simethicone Combined With Macrogol 4000 PEG Reduces Colon Bubble Formation in Colonoscopy Phase 4 Prospective Multicenter Real Life Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
XIMEPEG-RL
Brief Summary:
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation
Patients and Methods This prospective real-life phase 4 study was conducted from February 2020 to May 2021 in five private endoscopy centres among adult patients undergoing a colonoscopy Clinical endoscopic and histological parameters were collected on e-CRF The primary endpoint was the measurement of bubble formation in the various colon segments
Patients and Methods This prospective real-life phase 4 study was conducted from February 2020 to May 2021 in five private endoscopy centres among adult patients undergoing a colonoscopy Clinical endoscopic and histological parameters were collected on e-CRF The primary endpoint was the measurement of bubble formation in the various colon segments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None