Elkridge

Researchers are evaluating the effectiveness of TAR-210 compared to investigators choice of intravesical chemotherapy in people with intermediate-risk non-muscle invasive bladder cancer IR-NMIBC who have specific FGFR mutations or fusions. This Phase 3 randomized study aims to compare disease-free survival between these treatment options, with the goal of understanding which may better prevent recurrence or progression of the cancer. Participants are randomly assigned to one of two groups. Group A receives TAR-210, which is inserted into the bladder on Day 1 and removed after 12 weeks, with one insertion every 12 weeks over about one year. Group B receives intravesical chemotherapy using mitomycin C or gemcitabine, chosen by the investigator, given once weekly for 4 to 6 doses followed by maintenance treatment for at least six months up to one year. The study includes a substudy with similar treatment groups. During the trial, participants will undergo multiple cystoscopies and urinary tumor resections as needed to monitor for disease recurrence or progression. Researchers will measure disease-free survival from the time of randomization until recurrence, progression, or death over approximately four years. Additional assessments include quality of life questionnaires, adverse events monitoring, and survival outcomes. Participants are followed closely with various evaluations throughout the study duration.

Researchers are investigating treatments for participants with high-grade non-muscle invasive bladder cancer NMIBC that is unresponsive to Bacillus Calmette-Guerin BCG therapy. This phase 3 trial evaluates the safety and effects of nadofaragene firadenovec, a gene therapy, used alone or combined with chemotherapy or immunotherapy. The study aims to build on earlier findings where over half of participants achieved a complete response in a previous trial. Participants will be randomly assigned to receive one of the following nadofaragene firadenovec alone via intravesical instillation, nadofaragene firadenovec combined with intravesical gemcitabine and docetaxel chemotherapy, or nadofaragene firadenovec combined with intravenous pembrolizumab immunotherapy. The pembrolizumab arm is now closed to new participants, focusing enrollment on the other two arms. Treatments will be administered according to the study protocol to assess their effects on bladder cancer. During the trial, participants will undergo regular evaluations including tumor assessments, pathology staging, and monitoring for disease progression and adverse events for up to 36 months. The main outcomes measured include complete response rates at 3 and 6 months, durability of response, progression to muscle-invasive disease, need for cystectomy, and overall survival. Safety and tolerability will also be closely observed. Participants will be followed throughout the study duration, which extends up to the end of 2030.

Researchers are evaluating the safety and performance of the Glean Urodynamics System for monitoring the lower urinary tract. This prospective, open-label, single-arm interventional trial focuses on both in-clinic and extended monitoring periods. The study aims to assess how well this device works in clinical settings and during continued use outside the clinic. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software applications. Initially, monitoring occurs in-clinic, followed by discharge with the bladder sensor in place for up to 24 hours of additional monitoring at home. The sensor is removed within 24 hours after insertion. Seven days following sensor removal, participants provide a urine sample and receive a follow-up phone call 14 days after the device is removed. During the study, participants will undergo monitoring with the device and provide a urine sample after one week. Researchers will track any adverse events related to the Glean Urodynamics System from the time of enrollment until 14 days after device removal. Follow-up phone calls help ensure participant safety and gather additional information. Participation duration includes the initial monitoring period, sample collection, and follow-up, lasting a few weeks in total.

Researchers are evaluating how well Direct Selective Laser Trabeculoplasty DSLT lowers eye pressure in adult non-Caucasian patients with primary open angle glaucoma POAG. The study focuses on comparing eye pressure without glaucoma medications washed out eye pressure before and 6 months after the DSLT procedure. This research aims to better understand the effectiveness of DSLT in lowering intraocular pressure in this patient group. Participants will receive the DSLT treatment using the Belkin Vision Eagle Device on one or both eyes. The study includes follow-up visits at 1 month, 3 months, and 6 months after the procedure to monitor vision and eye pressure. These visits assess the reduction in eye pressure and whether participants need additional glaucoma medications or procedures during the 6 months after treatment. During the study, participants will have their vision and intraocular pressure measured at scheduled visits. Researchers will track the amount of eye pressure reduction, the proportion of eyes achieving significant pressure decrease, and the number of medication-free eyes at 6 months. Safety and the need for any extra glaucoma treatments will also be monitored. The total study duration for each participant is 6 months after the DSLT procedure.

Researchers are evaluating the safety and effectiveness of intravesical administration of detalimogene EG-70, a novel non-viral gene therapy, in patients with non-muscle invasive bladder cancer NMIBC. The study focuses on patients with carcinoma in situ CIS unresponsive to BCG therapy and other high-risk NMIBC patients, including those who are BCG-nafve or incompletely treated. The trial includes a Phase 1 dose-escalation to determine safety and recommended dose, followed by a Phase 2 to assess treatment effectiveness. Participants will receive EG-70 via bladder instillation with a catheter in cycles lasting about 12 weeks. Phase 1 involves up to four cycles with either two or four doses per cycle, aiming for a 60-minute retention time. Phase 2 participants receive four instillations per cycle for up to four cycles at the recommended dose. Those achieving complete response may continue with maintenance treatment involving two doses per 12-week cycle. A substudy includes a surfactant bladder rinse before EG-70 instillation, with a shortened administration time. During the study, participants undergo regular assessments including cystoscopy, urine cytology, and biopsies to monitor response and safety. Researchers track adverse events, treatment response rates, duration of response, progression-free survival, and quality of life over periods ranging from weeks to years. Safety monitoring follows standardized criteria, and participants may continue in maintenance cycles if responding. The total study duration extends up to approximately nine years from start to completion.

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.

This research aims to confirm the ongoing safety and performance of the NXT Urodynamics System in patients who require urodynamic studies for various urinary conditions. It focuses on patient groups including pediatric patients, adults with urinary incontinence or obstruction, overactive bladder, and those with neurological co-morbidities. The study is observational and evaluates the system in real-world clinical settings. Participants undergo the NXT urodynamic procedure, a diagnostic test used to assess bladder and urinary function. The study includes several patient sub-populations such as pediatric patients, male and female adults with obstructive or incontinence conditions, and adults with neurological issues. The study tracks the systems performance and safety during these procedures. During the study, researchers assess the performance and safety of the NXT system within a 120-minute evaluation period. Participants are monitored for any complications or issues related to the diagnostic procedure. The study involves patient questionnaires and informed consent processes to ensure accurate communication and data collection, with follow-up and data analysis continuing until March 2027.

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 the safety and efficacy of cretostimogene grenadenorepvec in participants with high-risk non-muscle-invasive bladder cancer NMIBC. This Phase 2, multi-arm, multi-cohort, open-label study includes participants who are either naive to Bacillus Calmette-Guerin BCG treatment, previously exposed to BCG, or unresponsive to BCG treatment. The study aims to compare different dosing methods and combinations with gemcitabine to better understand treatment effects in various NMIBC patient groups. The study is organized into several cohorts and arms based on the participants prior BCG treatment status and pathology. Cretostimogene grenadenorepvec is administered intravesically directly into the bladder using either the current or an alternative instillation method. In some arms, gemcitabine is also given either concurrently or sequentially with the study drug. Treatment involves weekly induction courses for six weeks, followed by reinduction if needed, and maintenance therapy over up to three years with treatments spaced every three to six months. Participants will undergo regular assessments including urine cytology, cystoscopy, upper tract evaluation, and biopsies or resections if indicated, every three months for the first two years and then every six months for up to four years or until disease recurrence. The study measures include complete response rates and high-grade event-free survival at various time points. Safety and duration of response are also monitored to evaluate the study treatments over the long term.

Prostate cancer is a common cause of illness and death among men worldwide, with black men facing earlier, more frequent, and aggressive forms of the disease. This study evaluates the Proclarixae blood test, designed to help identify men at risk for clinically significant prostate cancer, particularly in a diverse multi-ethnic US population. Current risk tools often lack accuracy for different ethnic groups, so this research aims to confirm Proclarixaes performance beyond European populations. Participants with elevated PSA levels between 2 and 10 ngmL, who are scheduled for a prostate biopsy, provide a blood sample before their biopsy. The blood is tested using Proclarixae, which measures two biomarkers, thrombospondin 1 and cathepsin D, combined with PSA levels and age to produce a risk score. Prostate biopsies are conducted as per usual clinical practice, and biopsy results are compared with Proclarixae scores to assess test accuracy. During the study, participants provide informed consent, blood samples, and diagnostic test results. Researchers review biopsy outcomes and compare them with Proclarixae results to evaluate its clinical accuracy. The main measure is how well Proclarixae predicts significant prostate cancer within 90 days from enrollment. Additional analysis includes how Proclarixae relates to other diagnostic tests like MRI or ultrasound. Participation lasts until biopsy results are collected, up to 90 days.