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NCT00588757 Clinical Trial

Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome

Trauma Clinical Trial

Official title:
Prospective Comparison Between OptEase and Gunter-Tulip

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00588757
Other study ID # SHEBA-07-4741-UR-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 25, 2007
Last updated January 8, 2008
Start date March 2008
Est. completion date March 2009

Study information
Verified date December 2007
Source Sheba Medical Center
Contact Uri Rimon, MD
Phone 97235302673
Email rimonu@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients referred for filter insertion

Exclusion Criteria:

- Young age (<18 years)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Optease IVC filters
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
• Gunter-Tulip IVC filters
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.

Locations
Country Name City State
Israel Sheba medical center Tel hashomer

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary comparing the two filters 1 year No
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