CorMatrix® frequently conducts post-market and clinical studies to further the development of and support of our unique products. Below is a list of current studies. For more information in participating in these or future trials please submit questions via the contact us form.
SECURE Study for the CorMatrix® CanGaroo® ECM® Envelope
- A multi-center post-market observational study to gather information on the use of the CanGaroo ECM Envelope. This study is anticipated to enroll up to 1000 subjects at 50 centers. The endpoints of the study are the proportion of subjects with CanGaroo related adverse events and the incidence of major pocket infection.
RECON Study for the CorMatrix® ECM® for Pericardial Closure
- A multi-center post-market observational study to gather information on the use of the Pericardial Closure. This study is anticipated to have 100 or more centers participate with no end point in number of enrolled subjects. The endpoint of the study is the proportion of subjects with device related adverse events.
PERFORM Study for the CorMatrix® ECM® for Femoral Arterial Reconstruction
- A 5 center, Phase IV, prospective, single arm, post-market observational study on the use of the CorMatrix ECM for vascular repair in femoral arterial reconstruction. This study is anticipated to have 5 centers enrolling up to 100 subjects. The endpoint of the study is the proportion of subjects with device related adverse events.
CorMatrix® ECM® Tricuspid Valve Replacement Safety & Early Feasibility Study
- An Early Feasibility Study (EFS) being carried out under an Investigational Device Exemption (IDE) to evaluate the feasibility of the CorMatrix ECM Tricuspid Valve as a tricuspid valve replacement in patients for the surgical management of tricuspid valve disease not amenable to repair, including tricuspid valve disease secondary to congenital heart disease. The study is intended to demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM Tricuspid Valve and increase the efficiency of the device development process by identifying appropriate modifications to the implant procedure or the device. The multi-center, prospective, single-arm study is anticipated to enroll up to 15 subjects at up to 8 clinical sites. CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Clinicaltrials.gov Identifier: NCT02397668