Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 6:41 PM
Study NCT ID:
NCT00588757
Status:
UNKNOWN
Last Update Posted:
2008-01-09
First Post:
2007-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Prospective Comparison Between OptEase and Gunter-Tulip
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
NOT_YET_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:
OptEase filters are easier to retrieve but the dwell time is shorter than the Gunter filters. There are more thrombi on the OptEase than on the Gunter at the time of retrieval. OptEase filter has a better infitration capabillity due to its diamond shape. OptEase filters will hjave more IVC occlusions as a complication.
Detailed Description:
We will isert the two filters blindly. We will follow the patients clinically and if needed we will add imaging exams. We will try to retrieve most filters.
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?: