Back to resultsComparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
Primary Purpose
Trauma, Deep Vein Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Optease IVC filters
Gunter-Tulip IVC filters
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring IVC filters, Trauma, Dwell time
Eligibility Criteria
Inclusion Criteria:
- All patients referred for filter insertion
Exclusion Criteria:
- Young age (<18 years)
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Optease filter
Tulip filter
Outcomes
Primary Outcome Measures
comparing the two filters
Secondary Outcome Measures
Full Information
NCT ID
NCT00588757
First Posted
December 25, 2007
Last Updated
January 8, 2008
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00588757
Brief Title
Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
Official Title
Prospective Comparison Between OptEase and Gunter-Tulip
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Deep Vein Thrombosis
Keywords
IVC filters, Trauma, Dwell time
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Optease filter
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tulip filter
Intervention Type
Device
Intervention Name(s)
Optease IVC filters
Intervention Description
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
Intervention Type
Device
Intervention Name(s)
Gunter-Tulip IVC filters
Intervention Description
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
Primary Outcome Measure Information:
Title
comparing the two filters
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients referred for filter insertion
Exclusion Criteria:
Young age (<18 years)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Rimon, MD
Phone
97235302673
Email
rimonu@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Rimon, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Rimon, MD
Phone
97235302673
Email
rimonu@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Uri Rimon, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
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