Deep Vein ThrombosisNCT05881798
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
An observational study of Deep Vein Thrombosis and Venous Thromboembolism, run by Cook Research Incorporated at 7 sites in 3 countries.
Trial summary
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Venous Thromboembolism, Pulmonary Embolism
- What is being tested?
- Celect Platinum Vena Cava Filter
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 2 Jun 2025to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Who may be able to join
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
Who cannot join
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari de Bellvitage
Barcelona, 08907
- Recruiting
Hospital Reina Sofia de Cordoba
Córdoba, 14004
- Recruiting
Parc Tauli
Sabadell, 08208
United Kingdom3 sites, 3 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
- Recruiting
Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, LS1 3EX
- Recruiting
Royal Liverpool Hospital
Liverpool, L7 8XP
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
- Being tested
- Celect Platinum Vena Cava Filter
- Keywords
- Celect Platinum Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celect Platinum Vena Cava FilterDevice
Inferior vena cava filter
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for the placement of a Celect Platinum Vena Cava Filter | Patients indicated for the placement of a Celect Platinum Vena Cava Filter Receives: Device: Celect Platinum Vena Cava Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter-related primary endpoint (safety)
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death.
Measured: Index procedure through 12-months post procedure
Filter-related primary endpoint (performance)
Performance:
Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration.
Measured: 12-months post procedure
Filter Retrieval-related primary endpoint
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death.
Measured: Through 30-days post procedure
Filter Retrieval-related primary endpoint
Technical retrieval success, defined as endovascular retrieval of complete filter.
Measured: At the time of retrieval procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start2 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881798
- Sponsor's protocol ID
- MDR-2126
- Status last verified
- Apr 2026
- First submitted
- 2 May 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
- ClinicalTrials.gov ID
- NCT05881798
- Acronym / sponsor ID
- MDR-2126
- Keywords
- Celect Platinum Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 31 May 2023 (actual)
- 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.
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for the placement of a Celect Platinum Vena Cava Filter | – | Device: Celect Platinum Vena Cava FilterPatients indicated for the placement of a Celect Platinum Vena Cava Filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Key inclusion criteria (2 listed)
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
Key exclusion criteria (1 listed)
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
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 |
|---|---|---|
| Celect Platinum Vena Cava FilterInferior vena cava filter | Device | Patients indicated for the placement of a Celect Platinum Vena Cava Filter |
Primary outcome
Filter-related primary endpoint (safety)
Time frame: Index procedure through 12-months post procedure
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death.
Filter-related primary endpoint (performance)
Time frame: 12-months post procedure
Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration.
Filter Retrieval-related primary endpoint
Time frame: Through 30-days post procedure
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death.
Filter Retrieval-related primary endpoint
Time frame: At the time of retrieval procedure
Technical retrieval success, defined as endovascular retrieval of complete filter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis and Venous Thromboembolism, run by Cook Research Incorporated at 7 sites in 3 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, United Kingdom, United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabina Andersen (+45 29 73 41 34, sabina.hjorth@cookmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter-related primary endpoint (safety) (time frame: Index procedure through 12-months post procedure). The study lists 4 primary outcomes in all. 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 17 Apr 2026.