Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602689
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2020-10-20
Brief Title:
Fibrin Glue After ESD for High Risk Patients of Bleeding
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm A Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm
Detailed Description:
Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding the size of the iatrogenic ulcer is expected to be 40mm or more or taking aspirin antiplatelet drugs and anticoagulants
After resection and hemostasis with ESD Fibrin glue Greenplast Q is applied to the iatrogenic ulcer at the end of the procedure and the control group will not be applied
After that observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks
After resection and hemostasis with ESD Fibrin glue Greenplast Q is applied to the iatrogenic ulcer at the end of the procedure and the control group will not be applied
After that observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks
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?:
False
Is an FDA AA801 Violation?:
None