OSCAR II STUDY - The ONCObind CTC Removal Study

The ONCObind Microbind® Affinity Blood Filter ( ONCObind) manufactured by ExThera Medical Corporation in Martinez, CA. The ONCObind filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin-coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. Literature search yielded over 60 publications and 500 treated patients with Seraph platform technology for pathogen removals without and significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of ONCObind consistent with the intended use. ExThera Medical concludes that the known and potential benefits of ONCObind, when used to treat patients with PDAC, outweigh the known and potential risks when used according to the intended use.

Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.