Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02685865
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-11-24
Brief Title:
Comparison of FCSEMS and Plastic Stents
Sponsor:
AdventHealth
Organization:
AdventHealth
Study Overview
Official Title:
Randomized Trial Comparing Fully Covered Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
Status:
COMPLETED
Status Verified Date:
2019-02
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:
WON-MVP
Brief Summary:
The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound EUS guided drainage of WON using FCSEMS and plastic stents The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy Orlando Florida
Detailed Description:
The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy Orlando FloridaThe sample size estimated for this study is 60 patients All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 11 ratio using a computer-generated randomized sequence It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance The statistician will be blinded to the stent type utilized
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