Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01457105
Status:
COMPLETED
Last Update Posted:
2011-10-21
First Post:
2011-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covered Self-expandable Metal Stents for Palliation of Malignant Biliary Strictures: Evaluation of a New Type of Stent
Sponsor:
Catholic University of the Sacred Heart
Organization:
Study Overview
Official Title:
PARTIALLY COVERED NITINOL "ComVi" STENT FOR PALLIATION OF MALIGNANT NON HILAR BILIARY OBSTRUCTION
Status:
COMPLETED
Status Verified Date:
2011-10
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:
self-expandable metal stents for palliation of malignant biliary strictures
Detailed Description:
The ComVi biliary stent (Taewoong Medical Inc., Seoul, Korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-PTFE) membrane sandwiched between two wire layers and has a weaker axial force than other stents.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
Patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.
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?: