TraumaNCT00588757
Comparison Between Two Optional IVC Filters Regardind Ease of Use,Complications and Outcome
A study testing Optease IVC filters and Gunter-Tulip IVC filters in people with Trauma and Deep Vein Thrombosis, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Deep Vein Thrombosis
- What is being tested?
- Optease IVC filters and Gunter-Tulip IVC filters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred for filter insertion
Who cannot join
- Young age (<18 years)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Tel HaShomer, 52621
Uri Rimon, MD, 97235302673, rimonu@sheba.health.gov.il
Uri Rimon, MD
About this study
Official title: Prospective Comparison Between OptEase and Gunter-Tulip
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.
Read the 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.
- Conditions
- Trauma, Deep Vein Thrombosis
- Being tested
- Optease IVC filters, Gunter-Tulip IVC filters
- Keywords
- IVC filters, Trauma, Dwell time
- Medical subject headings
- Wounds and Injuries, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optease IVC filtersDevice
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
Gunter-Tulip IVC filtersDevice
IVC filters will be implemented and evaluated for retrieval after 2-3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Optease filter Receives: Device: Optease IVC filters |
| 2 | Active comparator | Tulip filter Receives: Device: Gunter-Tulip IVC filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the two filters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Uri Rimon, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588757
- Sponsor's protocol ID
- SHEBA-07-4741-UR-CTIL
- Status last verified
- Dec 2007
- First submitted
- 25 Dec 2007
- Last updated
- 9 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between OptEase and Gunter-Tulip
- ClinicalTrials.gov ID
- NCT00588757
- Acronym / sponsor ID
- SHEBA-07-4741-UR-CTIL
- Conditions
- Trauma, Deep Vein Thrombosis
- Keywords
- IVC filters, Trauma, Dwell time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Optease IVC filtersOptease filter |
| 2 | Active comparator | Device: Gunter-Tulip IVC filtersTulip filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred for filter insertion
Key exclusion criteria (1 listed)
- Young age (<18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optease IVC filtersIVC filters will be implemented and evaluated for retrieval after 2-3 weeks. | Device | 1 |
| Gunter-Tulip IVC filtersIVC filters will be implemented and evaluated for retrieval after 2-3 weeks. | Device | 2 |
Primary outcome
comparing the two filters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri Rimon, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optease IVC filters and Gunter-Tulip IVC filters in people with Trauma and Deep Vein Thrombosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Rimon, MD (97235302673, rimonu@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the two filters (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2008; AzTrials last refreshed its copy on 1 Nov 2026.