Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443047
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-24
Brief Title:
Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
STITCH
Brief Summary:
The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps More precisely the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips
Detailed Description:
Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide ESD is the technique which provides a high-quality resection of these large polyps
Nevertheless several adverse events affect ESD especially in the colon They could be life-threatening call for or prolong the hospitalization require blood transfusion additional endoscopic or surgical procedures and increase costs
Thus preventing these adverse events is an important clinical and medico-economic objective Endoscopic closure of post-ESD defects could reduce this risk However closing these large defects with conventional clips can be difficult unsuccessful and prolong the duration of the whole procedure A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time
Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
Nevertheless several adverse events affect ESD especially in the colon They could be life-threatening call for or prolong the hospitalization require blood transfusion additional endoscopic or surgical procedures and increase costs
Thus preventing these adverse events is an important clinical and medico-economic objective Endoscopic closure of post-ESD defects could reduce this risk However closing these large defects with conventional clips can be difficult unsuccessful and prolong the duration of the whole procedure A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time
Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None