Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-02 @ 6:32 PM
Study NCT ID:
NCT02625792
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Hemostatic Powder (Endo-clotTM) in Prevention of Bleeding Within High Risk Patients After ESD
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-01
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:
None
Brief Summary:
SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer bleeding rate reported about 5% \~ 10% of all cases. Antiplatelet or anti-coagulation treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer bigger than 40mm in size is also associated.
Though several previous study have failed to show efficacy of 2nd look EGD, but those reports pointed out that visible vessels with current bleeding or highly suspect of recent bleeding (Forrest type IA\~IIB) was observed about 10\~20% of patients. Such patients are at high risk of bleeding.
So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And finally this protective effect might have an effect for prophylaxis of post ESD ulcer bleeding.
Though several previous study have failed to show efficacy of 2nd look EGD, but those reports pointed out that visible vessels with current bleeding or highly suspect of recent bleeding (Forrest type IA\~IIB) was observed about 10\~20% of patients. Such patients are at high risk of bleeding.
So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And finally this protective effect might have an effect for prophylaxis of post ESD ulcer bleeding.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: