Palm Beach

This trial evaluates the safety and effectiveness of intratumoral Alpha DaRT-224, a device delivering diffusing alpha-emitter radiation, in treating immunocompromised patients with cutaneous squamous cell carcinoma SCC. The study aims to measure the objective response rate ORR using RECIST v1.1 criteria and track progression-free survival PFS, overall survival OS, and local tumor control up to 12 months after treatment. It is a multicenter, single-arm, open-label clinical study involving up to 28 participants. Participants will receive DaRT seeds, which are encapsulated Radium-224 radioactive sources inserted directly into the SCC tumor. These sources emit short-lived alpha particles locally in the tumor microenvironment. The seeds remain implanted for 14 to 21 days before removal. The treatment targets tumors up to 7 cm in size with single lesions that can be fully covered by the radiation sources. The study does not include a comparison group. During the study, participants will undergo multiple CT scans and blood tests to monitor tumor response and safety. Researchers will assess the best overall tumor response starting from the time of DaRT seed removal. Adverse events related to the device will be classified and recorded according to established criteria. Patients must provide informed consent and will be followed for up to 12 months after seed insertion to evaluate survival and tumor control outcomes.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System CMCS in treating patients with heart failure who also have functional mitral regurgitation FMR. This prospective, randomized, double-blinded, sham-controlled trial aims to better understand how this device may impact heart function and symptoms in people with this condition. Participants will be randomly assigned to one of two groups one group will receive the Carillon implant along with guideline-directed heart failure medications, while the other group will receive only the heart failure medications and a sham procedure to preserve blinding. Before randomization, patients will undergo specific heart imaging tests and evaluations to determine eligibility and suitability for the device placement. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety and heart function. After 24 months, all participants will be informed of their group assignment and followed annually for an additional three years. During the study, researchers will assess various health outcomes including freedom from major adverse events at 12 months and clinical improvement at 24 months. Additional measures will include changes in heart valve function, heart size, walking ability, heart failure symptoms, hospitalizations, and quality of life. Participants will have regular heart imaging, clinical evaluations, and questionnaires to track these outcomes. The total participation time may extend up to five years with long-term monitoring to better understand the devices impact over time.