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.

Not Applicable

Completed

• Conditions: Venous thromboembolism; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Blood - Haematological diseases

• Registration Number: ACTRN12611000621910
• Lead Sponsor: Barons Medical Consulting Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-17
• Study Completion: 2013-09-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified