Millburn

Researchers are creating a registry to better understand treatment choices and outcomes for pancreatic cancer patients undergoing irreversible electroporation IRE, a type of soft tissue ablation. The study aims to gather evidence to help doctors provide the best care for patients with pancreatic tumors that cannot be surgically removed. This research also seeks to learn about the concerns, limitations, and complications experienced by earlier users of this treatment. The registry collects clinical and pathological data from multiple centers on patients with pancreatic neoplasms who are eligible for soft tissue ablation as determined by their doctors. Data entry is web-based and includes all treatments, follow-ups every 3-4 months in the first year and every 6 months in the second year, for up to two years or until death. Participating institutions submit detailed data and receive annual certificates acknowledging their contribution. Participants provide de-identified information about their treatment and outcomes, monitored for adverse events for up to five years. The registry supports quality assurance by reviewing outcomes and helping centers improve if needed. Researchers focus on adverse events and overall survival, gathering information to improve future ablation treatments for unresectable pancreatic tumors. The study duration allows comprehensive long-term follow-up and data analysis.

This research evaluates semen quality after treatment with the Optilume Urethral Drug Coated Balloon DCB in men aged 22 to 65 who have an anterior urethral stricture treatable with this device. It is a single-arm, prospective study involving 34 male participants across multiple sites in the United States. The study aims to assess various urinary and sexual function outcomes following treatment. Participants receive the Optilume Urethral DCB, a catheter with a balloon coated with the drug paclitaxel that transfers the medication to the urethral wall upon inflation. The study includes follow-up visits at 30 days, 3 months, 6 months, and 12 months after treatment to monitor symptoms and function. Semen quality is tested before treatment and at 3 and 6 months post-treatment, with additional testing up to 12 months if abnormalities are detected. During the study, participants undergo evaluations of urinary symptoms, sexual function, and voiding function at scheduled intervals. Semen samples are collected to assess sperm characteristics. Safety endpoints are reviewed at 3 and 6 months. Follow-up continues for up to a year or longer if semen abnormalities persist, ensuring comprehensive monitoring of treatment effects and participant well-being.

Researchers are evaluating whether adding renal artery denervation RDN to pulmonary vein isolation PVI improves long-term outcomes for patients with persistent atrial fibrillation AF, including those with controlled or no hypertension. This randomized controlled pilot trial builds on prior findings that RDN plus PVI reduced AF recurrence in patients with uncontrolled hypertension. The study aims to test the antiarrhythmic benefits of combining these treatments using implantable loop recorders for detailed heart rhythm monitoring. The study compares two groups one receiving catheter ablation using cryoballoon energy to isolate pulmonary veins PVI alone and another receiving the same PVI procedure followed by radiofrequency renal artery denervation targeting both renal arteries. This approach seeks to reduce cardiac sympathetic stimulation, which may contribute to AF. The trial includes a single-blind design and uses implantable loop recorders to track AF burden over time. Participants will undergo the assigned procedures and then be followed for 12 months, with regular assessments including blood pressure monitoring, evaluation of cardiac sympathetic activity, safety checks, and quality of life questionnaires. Outcomes include measuring AF burden at one year, procedural complications, changes in blood pressure, progression to persistent AF, hospital visits, and overall quality of life. The trial will provide important data on the safety and potential benefits of adding RDN to standard PVI therapy.