Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-06 @ 9:36 AM
Study NCT ID:
NCT00990366
Status:
TERMINATED
Last Update Posted:
2011-10-12
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
Sponsor:
Turku University Hospital
Organization:
Study Overview
Official Title:
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
Status:
TERMINATED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis results, study terminated 5/2010
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.
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?: