NCT05127915 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dria SJ, Eggers MD
In vitro evaluation of clot capture efficiency of an absorbable vena cava filter. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):472-8. doi: 10.1016/j.jvsv.2016.05.006. Epub 2016 Jul 25.
Eggers M, Rousselle S, Urtz M, Albright R, Will A, Jourden B, Godshalk C, Dria S, Huang S, Steele J
Randomized Controlled Study of an Absorbable Vena Cava Filter in a Porcine Model. J Vasc Interv Radiol. 2019 Sep;30(9):1487-1494.e4. doi: 10.1016/j.jvir.2019.03.010. Epub 2019 Jun 13.
Eggers MD, McArthur MJ, Figueira TA, Abdelsalam ME, Dixon KP, Pageon LR, Wallace MJ, Huang SY
Pilot in vivo study of an absorbable polydioxanone vena cava filter. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):409-420. doi: 10.1016/j.jvsv.2015.03.004. Epub 2015 Jun 18.
Eggers MD, Reitman CA
In vitro analysis of polymer candidates for the development of absorbable vascular filters. J Vasc Interv Radiol. 2012 Aug;23(8):1023-30. doi: 10.1016/j.jvir.2012.05.039.
Elizondo G, Eggers M, Falcon M, Trevino M, Marrufo R, Perez C, Nunez E, Moreno R, Mitchell A, Sheppard A, Dria S, Jay T, Kirk R, Hovsepian D, Steele J
First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary Embolism. J Vasc Interv Radiol. 2020 Nov;31(11):1817-1824. doi: 10.1016/j.jvir.2020.07.021. Epub 2020 Sep 29.
Huang SY, Eggers M, McArthur MJ, Dixon KA, McWatters A, Dria S, Hill LR, Melancon MP, Steele JR, Wallace MJ
Safety and Efficacy of an Absorbable Filter in the Inferior Vena Cava to Prevent Pulmonary Embolism in Swine. Radiology. 2017 Dec;285(3):820-829. doi: 10.1148/radiol.2017161880. Epub 2017 Jul 14.

A Prospective, Multicenter, Pivotal Study With Randomized Controlled Prophylactic and Independent Therapeutic Cohorts to Evaluate the Safety and Efficacy of an Absorbable Vena Cava Filter for Pulmonary Embolism Prevention

Details for clinical trial NCT05127915

Clinical trial NCT05127915 - References