Millburn

This research aims to create a registry to better understand treatment choices and outcomes for patients with pancreatic cancer undergoing irreversible electroporation (IRE), a type of soft tissue ablation. The goal is to develop a solid evidence base to help doctors provide the best care to patients needing surgical interventions for pancreatic tumors. The study also seeks to learn about the limitations, concerns, and complications experienced by earlier users of this ablation treatment. Participants undergo soft tissue ablation for pancreatic cancer as judged feasible by their treating physician. The registry collects detailed clinical and pathological data from multiple centers to support future research. Treatment details and follow-up data are entered into a web-based system, including all treatments and results for up to two years or until the patient's death. Follow-ups typically happen every 3-4 months during the first year and every 6 months in the second year. Participants provide de-identified data, which is periodically audited for quality. Researchers monitor adverse events and complications related to IRE treatment for up to five years. The registry supports participating institutions by reviewing outcomes and offering assistance to improve care when needed. Overall, the study focuses on gathering long-term information to enhance treatment understanding and patient care in pancreatic cancer.

Researchers are evaluating semen quality in men aged 22 to 65 who have an anterior urethral stricture treatable with the Optilume Urethral Drug Coated Balloon (DCB). This single-arm, prospective Phase 4 study aims to assess andrology parameters following treatment with this device. The study will enroll 34 men at up to ten sites across the United States to monitor urinary, sexual, and voiding functions over time. Participants will be treated with the Optilume Urethral DCB, a catheter with a balloon coated in paclitaxel, a drug designed to transfer to the urethral wall when the balloon is inflated. Clinical follow-up visits are planned at 30 days, 3 months, 6 months, and 12 months after treatment to evaluate symptoms and functions related to the lower urinary tract and sexual health. Semen quality will be assessed at baseline, 3 months, and 6 months post-treatment, with further assessments at 12 months and beyond if abnormalities are detected at 6 months. During the study, participants will provide semen samples and undergo evaluations of urinary and sexual function. Researchers will monitor semen quality parameters such as sperm count, concentration, motility, and morphology. Safety will also be tracked, focusing on a primary safety endpoint at 3 months. The total follow-up period extends to at least 12 months, with additional monitoring if needed to ensure semen quality returns to normal.

Researchers are studying atrial fibrillation (AF), focusing on whether adding renal artery denervation (RDN) to pulmonary vein isolation (PVI) improves treatment outcomes. PVI is the main catheter ablation technique used for AF but has limitations, especially for persistent AF. The study builds on prior research showing that RDN plus PVI reduced AF recurrence in patients with uncontrolled hypertension, now testing this combination in patients with persistent AF who have controlled or no hypertension. The trial compares two groups: one receiving PVI alone and the other receiving PVI plus RDN. PVI involves catheter ablation using cryo energy delivered via a cryoballoon, while RDN uses radiofrequency energy applied to multiple sites within each major renal artery. All participants will have implantable loop recorders placed to continuously monitor heart rhythm and measure AF burden over time. This is a randomized, controlled, single-blinded trial assessing long-term effects. Participants will undergo assessments including monitoring of AF burden at one year, blood pressure, cardiac autonomic nervous system function, and safety outcomes such as procedural complications. Researchers will also track clinical events like progression to persistent AF, repeat ablations, emergency visits, hospitalizations, and quality of life changes. Follow-up includes post-procedural visits and adherence to study requirements, aiming to evaluate the effectiveness and safety of adding RDN to PVI for persistent AF patients.