None listed
Conditions
Brief summary
The research project will test whether a new device, the Novate IVC Filter, can be placed safely in a vein called the inferior vena cava, and then stay in place filtering blood for any clots that may occur. This filter is intended to prevent a clot from moving through the body to lungs. This research project will be the first time that the Novate IVC Filter will have been used in humans, however, the device has undergone all of the testing required by law to ensure that it is safe to use in humans and is very similar to other filter devices routinely used in this hospital. The device being tested in this research project differs from the normal device offered in this hospital because of its design and the way in which it works. Most hospitals would usually use a retrievable (removable) filter in this type of operation. This type of filter may be removed after a period of time and this means that the patient would have to undergo a second operation to remove the filter. The Novate IVC Filter doesn’t require the patient to undergo this second, removal operation. This is because after 60 days when the patient no longer needs it, the filter is designed to open up, the patient's blood will no longer be filtered and the remaining parts of the device will then be incorporated into the walls of the patient's vein over time. The vein wall will grow tissue over the remaining parts of the filter and cover them up, leaving the inside of the vein clear.
Interventions
Novate Medical Ltd. (Galway, Ireland) has developed an IVC filter intended to be used for protection against pulmonary embolism (PE). The Novate IVC Filter (The Device) is designed for percutaneous placement in the IVC (via either femoral vein or the right jugular vein) and is designed to trap emboli and reduce the risk of PE while maintaining caval patency.
The filtering cone of The Device is similar in design to existing permanent and retrievable devices, but it has a bioabsorbable filament wh
Novate Medical Ltd. (Galway, Ireland) has developed an IVC filter intended to be used for protection against pulmonary embolism (PE). The Novate IVC Filter (The Device) is designed for percutaneous placement in the IVC (via either femoral vein or the right jugular vein) and is designed to trap emboli and reduce the risk of PE while maintaining caval patency. The filtering cone of The Device is similar in design to existing permanent and retrievable devices, but it has a bioabsorbable filament which holds the filter arms in a filtering configuration. The bioabsorbable filament is designed to maintain the filtering configuration for a minimum of 60 days, after which time it is hydrolysed (decomposed by reaction with water) by the body’s natural processes. This allows the filter arms to open and retract to the IVC wall, where, over time, they become endothelialised and permit unobstructed blood flow in the IVC. This design allows for temporary IVC filtration which is intended to reduce the incidence of PE during the early high risk period, but removes the requirement for a second interventional procedure to remove The Device thereby avoiding the risks associated with the currently available devices. Physicians determine access routes depending on preference and the patient's medical condition, and standard procedures apply. The time taken by physicians to perform the insertion of the Novate IVC Filter is comparable to existing permanent and retrievable devices, and can take as little as 1/2 hour.
Sponsors
Barons Medical Consulting Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria in order to be included in the NOVEL Study: 1) The subject must be considered to have a temporary high risk for PE for a period of less than 60 days from Device implantation, and that placement of a permanent IVC filter is not required. Subjects must fall into one of the following categories: a) Surgical patients undergoing procedures historically associated with a high risk of venous thromboembolism. b) Trauma patients who are considered to be at high risk of DVT and PE. c) Medical patients who are considered to be at high risk of DVT and PE d) Any patient with a temporary high risk of DVT and PE and a transient contra indication to anti coagulants 2) The subject must have a patent femoral or internal jugular vein. 3) The subject or legal guardian must have signed the informed consent document. 4) The subject agrees to return for recommended visits and comply with protocol follow-up
Exclusion criteria
Subjects must not meet any of the following criteria: 1) Age < 18 years. 2) Presence of an existing caval filter. 3) Thrombus within the IVC 4) Indication for a permanent filter at the time of initial evaluation. 5) Uncontrollable coagulopathy. 6) Short life expectancy < 12 months. 7) Metastatic malignancy. 8) Vena cava diameter with an average of over 28 mm, (average of dimension in anteroposterior view and lateral view using vena cava sizing catheters) or the marker bands on The Device’s introducer sheath. 9) Infrarenal IVC length < 9cm 10) Contrast allergy that cannot be adequately pre-medicated. 11) The subject is at risk of septic embolism. 12) The subject has sepsis. 13) The subject has an infection at the intended access site (alternate access site may be used). 14) The subject has hypersensitivity to any of the components of The Device, specifically, nickel and titanium. 15) The subject has impaired renal function (creatinine> 2.0). 16) The subject is pregnant or planning to become pregnant within the next 12 months 17) The subject has an intellectual or mental impairment sufficient to prevent them from understanding the patient information leaflet
Outcome results
None listed