Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000621910
Ethics application status
Approved
Date submitted
15/06/2011
Date registered
17/06/2011
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Date results information initially provided
22/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Novate First In Man Clinical Study for adult patients needing an Inferior Vena Cava Filter due to their temporary risk of developing a clot in the lungs.
Scientific title
The Novate Inferior Vena Cava Filter First In Man Clinical Study to determine the technical success of the device in adult subjects at temporary high risk of thromboembolism.
Secondary ID [1] 262287 0
None
Universal Trial Number (UTN)
U1111-1122-0779
Trial acronym
The NOVEL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism 267982 0
Condition category
Condition code
Cardiovascular 268114 268114 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 268120 268120 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266683 0
Treatment: Devices
Intervention code [2] 266785 0
Prevention
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266863 0
The primary study endpoint is the technical success of The Device which is defined as deployment of The Device at the desired site, with the absence of device tilting, migration, fracture, thrombosis, stenosis, IVC damage, or significant complications at the access vein site.
At the time of deployment, subjective assessments will be made on the ease of delivery and deployment of The Device. The absence of tilting or migration will be documented by venacavagram and will be independently assessed. Any complications related to Device use will also be reported.
Timepoint [1] 266863 0
Index procedure (Day 0), and Post implantation: 45 Day, 60 day, 120 day, 180 day and 12 months.
Secondary outcome [1] 276519 0
(i) Successful conversion of The Device to the non filtering configuration within 180 days of implantation as assessed by X-ray.
Timepoint [1] 276519 0
60 day, and 120 day and 180 day follow ups.
Secondary outcome [2] 276545 0
(ii) Clinical success of The Device, defined as absence of PE and IVC occlusion related to the device, as assessed by CT Venogram/ Standard Venogram, and/or X-ray.
Timepoint [2] 276545 0
Index procedure (Day 0), and Post implantation: 45 Day, 60 day, 120 day, 180 day and 12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Investigators will assess any patients referred for management of existing or potential venous thromboembolic disease and determine, using appropriate testing procedures, their suitability for the device. They patients must meet the inclusion and exclusion criteria as detailed in the approved protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2009
Actual
14/12/2009
Date of last participant enrolment
Anticipated
Actual
7/07/2011
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
30
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 4062 0
2050
Recruitment postcode(s) [2] 4063 0
2170
Recruitment postcode(s) [3] 4064 0
2137
Recruitment postcode(s) [4] 4065 0
3004
Recruitment outside Australia
Country [1] 3606 0
Chile
State/province [1] 3606 0
Santiago

Funding & Sponsors
Funding source category [1] 267169 0
Commercial sector/Industry
Name [1] 267169 0
Barons Medical Consulting Pty Ltd
Country [1] 267169 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Barons Medical Consulting Pty Ltd
Address
25- 27 Granard Avenue
Park Orchards,
Victoria, 3114
Country
Australia
Secondary sponsor category [1] 266244 0
None
Name [1] 266244 0
Address [1] 266244 0
Country [1] 266244 0
Other collaborator category [1] 252036 0
Commercial sector/Industry
Name [1] 252036 0
Novate Medical Ltd
Address [1] 252036 0
First Floor
Block 11
Galway Technology Park
Parkmore
Galway
Country [1] 252036 0
Ireland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269158 0
SSWAHS (RPAH ZONE)
Ethics committee address [1] 269158 0
Sydney South West Area Health Service
Locked Bag 7017
LIVERPOOL NSW 1871
Ethics committee country [1] 269158 0
Australia
Date submitted for ethics approval [1] 269158 0
Approval date [1] 269158 0
14/09/2009
Ethics approval number [1] 269158 0
HREC/09/RPAH/330
Ethics committee name [2] 269164 0
The Alfred Ethics Committee
Ethics committee address [2] 269164 0
The Alfred Hospital, Commercial Road, Prahran, Victoria, 3004,
Ethics committee country [2] 269164 0
Australia
Date submitted for ethics approval [2] 269164 0
Approval date [2] 269164 0
13/01/2011
Ethics approval number [2] 269164 0
HREC 398/10

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32677 0
Prof Robert Lusby
Address 32677 0
Level 1, Building 75, Hospital Road, Clinical Sciences, Concord Repatriation Hospital, Concord, NSW, 2139.
Country 32677 0
Australia
Phone 32677 0
+61297676842
Fax 32677 0
Email 32677 0
[email protected]
Contact person for public queries
Name 15924 0
Ms Vanessa Lee
Address 15924 0
Novate Medical, 39/40 Upper Mount Street
Dublin, 2
Ireland
Country 15924 0
Ireland
Phone 15924 0
+35391750030
Fax 15924 0
+61398799997
Email 15924 0
[email protected]
Contact person for scientific queries
Name 6852 0
Prof Professor Robert Lusby
Address 6852 0
Professor of Surgery and Head of Vascular Surgery
Concord Clinical School (C22)
Concord Repatriation General Hospital
Hospital Road
Concord 2137
NSW
Country 6852 0
Australia
Phone 6852 0
+61297676842
Fax 6852 0
+61297676894
Email 6852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 342999-(Uploaded-18-11-2020-13-52-32)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.