Culpeper

Researchers are evaluating the safety and performance of the Enhanced Lithotripsy System (ELS) for treating urinary stones in adults aged 21 and older. The ELS uses low pressure ultrasound combined with microbubbles to break urinary stones into small fragments that can pass with minimal discomfort. The study focuses on patients with a single urinary stone located in the ureter, sized between 5 mm and 10 mm, and meeting specific density and treatment guidelines. Participants will receive the experimental ELS procedure designed to fragment stones using ultrasound activation of microbubbles in the urine. This is a single-arm trial where all qualifying patients undergo the ELS treatment. After the procedure, participants will be monitored primarily for the presence or absence of stone fragments using CT scans at 30 days, with a follow-up scan at 60 days if stones remain. During the study, participants will have CT scans to check stone status, and assessments will be made on changes in pain, quality of life, and return to daily activities or work. The study period includes evaluations at 30 days post-treatment and possibly at 60 days for those with remaining stones. The trial aims to observe safety and treatment effects without the use of a comparison group.

Researchers are evaluating treatment options for women aged 65 and older with early-stage estrogen receptor positive (ER+) breast cancer. This Phase III, multisite study compares two groups: one receiving 3 months of pre-operative endocrine therapy (pre-ET) before breast-conserving surgery (BCS), and the other proceeding directly to surgery without pre-ET. The study aims to understand how pre-ET influences decisions about radiation therapy (RT) and endocrine therapy (ET) use, addressing concerns of over- and under-treatment in this population. Participants will be randomly assigned to either receive 90 days of pre-ET using tamoxifen or an aromatase inhibitor before surgery or to move directly to BCS as standard care. In both groups, the choice to omit or administer RT will be made by patients and their physicians. Although not required by the study, all patients may be recommended to take adjuvant ET as appropriate, with adherence monitored for two years. The study evaluates whether pre-ET affects treatment choices and tolerance to endocrine therapy. During the study, researchers will assess patient-reported outcomes such as tolerance and compliance with ET through surveys. The main outcomes measured at 24 months include the proportion of patients who omit RT and do not adhere to ET, and those treated with BCS plus RT and ET. Secondary assessments cover decision conflict, regret, quality of life, early side effects of ET, and long-term cancer outcomes over five years. Participants will be followed through surgery, treatment, and monitoring phases to track treatment adherence and cancer recurrence.