The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward…
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done…
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk…