Elkridge

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are evaluating the safety and effectiveness of intravesical nadofaragene firadenovec alone or combined with chemotherapy or immunotherapy in people with high-grade Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS) with or without high-grade Ta/T1 disease. This phase 3 trial builds on earlier findings where over half of participants achieved a complete response after treatment with nadofaragene firadenovec alone at 3 months. The study aims to better understand treatment options for patients who have not responded to BCG therapy. Participants will receive intravesical nadofaragene firadenovec, a gene therapy designed to boost immune response by delivering the human interferon alfa-2b gene directly into the bladder. Some participants may also receive chemotherapy drugs gemcitabine and docetaxel, or the immunotherapy pembrolizumab administered through intravenous infusion. The treatments are given inside the bladder or by IV infusion as appropriate, and the study will assess these approaches alone or in combination. During the study, participants will be closely monitored for response to treatment, particularly looking for complete response up to 6 months after starting therapy. Researchers will regularly evaluate participants’ health status and tumor response, including safety assessments and follow-up visits over the course of the trial. The study requires participants to be available for the entire duration and includes various clinical assessments to track effectiveness and side effects.

This research aims to evaluate the safety and performance of the Glean Urodynamics System for monitoring lower urinary tract function. It is a prospective, open-label, single arm interventional trial involving adult patients eligible for urodynamics testing. The study focuses on conditions related to urinary bladder overactivity, benign prostatic hyperplasia, urinary incontinence, and other lower urinary tract dysfunctions. Participants will have the Glean Urodynamics System inserted during an in-clinic ambulatory monitoring period. After this, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, for no longer than 24 hours. The sensor will be removed within 24 hours of insertion. Seven days after sensor removal, participants will provide a urine sample, and they will receive a follow-up phone call 14 days post-removal to assess any adverse events. During the study, researchers will monitor participants from enrollment until 14 days after device removal for any qualifying adverse events related to the device. The study includes collection of urine samples and follow-up communications to ensure participant safety. Participants are expected to be involved in the monitoring period, sample collection, and follow-up assessments over a total duration spanning approximately two weeks after device removal.

Researchers are evaluating how Direct Selective Laser Trabeculoplasty (DSLT) affects eye pressure in adult non-Caucasian patients with primary open angle glaucoma. The study focuses on measuring the eye pressure without glaucoma medications six months after the DSLT procedure and comparing it to eye pressure before the procedure. The trial also assesses the success rate in reducing eye pressure by at least 20%, the number of patients who remain medication-free, the need for additional treatments, and the impact of trabecular meshwork pigmentation on results. Participants will receive the DSLT treatment using the Belkin Vision Eagle Device in one or both eyes. The study includes follow-up visits at 1 month, 3 months, and 6 months after the procedure to check vision and measure eye pressure. The main comparison is between the eye pressure measured at six months post-treatment and the baseline eye pressure before treatment without medications. During the study, participants will have their eye pressure and vision tested at scheduled visits. Researchers will track the reduction in intraocular pressure, medication use, and any need for further interventions. The primary outcome is the change in eye pressure six months after DSLT when not using glaucoma medications. This helps determine how well DSLT can control eye pressure over time in this patient group.

Researchers are evaluating the safety and effectiveness of EG-70, a new gene therapy designed to trigger a local immune response in the bladder, for patients with non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS). This trial includes patients who did not respond to BCG therapy as well as those who are BCG-nafve or received incomplete BCG treatment. The study consists of two phases: Phase 1 focuses on safely determining the recommended dose, and Phase 2 assesses how well the treatment works. In Phase 1, patients receive up to four cycles of EG-70 administered directly into the bladder via catheter, with each cycle lasting about 12 weeks and involving either 2 or 4 doses per cycle. In Phase 2, patients receive up to four 12-week treatment cycles at the recommended dose, followed by maintenance treatment cycles if they achieve a complete response. Maintenance cycles involve two doses per 12-week period, and patients may receive up to eight maintenance cycles total. The therapy is delivered as a 50 mL bladder instillation with a targeted retention time of 60 minutes. Participants will have regular assessments including exams, urine cytology, and biopsies to monitor tumor response and safety. Researchers will track adverse events over approximately 2 to 3 years and measure the percentage of patients achieving a complete response at 48 weeks. Safety evaluations will follow standard criteria, and follow-up will continue for those with ongoing treatment benefits. Total participation may last several years, depending on individual response and treatment cycles.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research aims to confirm the ongoing safety and effectiveness of the NXT urodynamic system in patients who need urodynamic studies. The study focuses on people with urinary conditions such as urinary incontinence, urinary obstruction, overactive bladder, neurogenic bladder, and urge urinary incontinence. It evaluates the device's performance when used in typical patient groups requiring this diagnostic procedure. Participants will undergo a urodynamic procedure using the NXT system, which is a diagnostic test intended to assess bladder and urinary function. This procedure forms the core intervention of the study, as researchers monitor how well the system works and whether it remains safe for patients during and after use. During the study, researchers will assess the NXT system’s performance and safety over a period of 120 minutes. Participants will be monitored closely, and the study involves collecting data to ensure the device meets safety standards and functions as planned. The total duration of involvement corresponds to these assessment periods, focusing on immediate and ongoing outcomes related to the device's use.

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 evaluating the safety and effectiveness of cretostimogene grenadenorepvec in adults with high-risk non-muscle-invasive bladder cancer (NMIBC) in this Phase 2, open-label study. The study includes multiple groups based on prior Bacillus Calmette-Guerin (BCG) treatment status: BCG-nave, BCG-exposed, and BCG-unresponsive or exposed. It aims to assess disease control and response in these different patient groups using cretostimogene alone or combined with gemcitabine. Participants are assigned to various cohorts and arms depending on their NMIBC subtype and treatment history. Treatment involves weekly instillations of cretostimogene for six weeks, with a possible reinduction course at 3 months if high-grade disease remains. Maintenance therapy follows with three weekly treatments every three months in the first year and every six months during the second and optional third years. Cohort CX participants receive cretostimogene plus gemcitabine either concurrently or sequentially. Throughout the study, participants undergo regular evaluations including urine cytology, cystoscopy, upper urinary tract assessment, and biopsies if needed every 3 months for 2 years, then every 6 months for an additional 2 years or until disease returns. The main outcomes measured include complete response rates at 11 and 24 weeks and event-free survival over 48 months, with ongoing safety monitoring during this period.

Researchers are evaluating the impact of a urine test called Cxbladder Triage Plus on the number of cystoscopies performed in adult patients with microhematuria, which is a condition where a small amount of blood is found in the urine only visible under a microscope. Microhematuria can have many causes, including bladder cancer, which is a major concern but is found in only a few patients. The trial focuses on this group of patients who visit a urologist because of microhematuria to understand if the test can influence the decision to perform cystoscopy, a procedure where a small camera is inserted into the bladder to look for cancer or other issues. Participants provide a urine sample that is tested using Cxbladder Triage Plus, which detects genetic material linked to urothelial carcinoma, the most common type of bladder cancer. Patients are randomly assigned to either a test group or a control group. In the test group, urologists receive the test results and discuss them with patients to decide together whether to proceed with cystoscopy. The control group receives standard care without the test results. If the urologist chooses not to follow the test recommendation, they complete a survey explaining their decision. Data on procedures performed and diagnoses are collected for about 9 months. During the study, researchers track how many cystoscopies are performed within 3 months after the decision point. Participants are monitored to see how the use of the Cxbladder Triage Plus test affects the number of cystoscopies compared to usual care. The study lasts up to 9 months and includes evaluations of procedures and diagnoses to assess the test's clinical utility.