Syosset

Researchers are evaluating the safety and effectiveness of the FloStent, a medical device designed to treat men experiencing symptoms of Benign Prostatic Hyperplasia (BPH). This clinical study compares the FloStent to a sham procedure, which involves flexible cystoscopy without deploying the device. The purpose is to assess how well the FloStent improves urinary symptoms in men with BPH. Participants will undergo a flexible cystoscopy. Those assigned to the treatment group will have the FloStent deployed during the procedure, while those in the control group will have the cystoscopy without device deployment. The study is designed as a prospective, multicenter, double-blind, randomized trial ensuring unbiased results. During the 12-month study period, researchers will monitor changes in participants' International Prostate Symptom Score (IPSS) to measure symptom improvement. Participants must complete all study visits and protocols as part of their involvement. Safety and effectiveness outcomes will be carefully tracked throughout the trial.

Researchers are investigating the effects of Tradipitant on nausea and vomiting caused by GLP-1 receptor agonist use in adults who are either overweight with at least one weight-related condition or have class I or class II obesity. This Phase 3 study compares Tradipitant to a placebo to evaluate its ability to reduce these symptoms. Participants will be randomly assigned to receive either oral Tradipitant capsules or oral placebo capsules. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The treatment period involves monitoring symptoms closely to assess the impact of Tradipitant compared to placebo. During the study, participants will keep a daily symptom diary to track vomiting episodes and nausea. Researchers will focus on the proportion of participants experiencing at least one vomiting episode per week. The study includes safety monitoring and will last at least one week, with careful assessments to understand the treatment's effects.

Researchers are conducting a non-interventional, open-label, observational study across multiple sites to collect real-world data on the use of an autologous hair follicle derived secretome topical cosmetic product. This product is studied as an addition to various medical aesthetic procedures, focusing on its application for conditions such as post-procedural erythema. The study includes adults aged 18 to 60 of any skin type who are planning to undergo these aesthetic treatments. Participants will use the Acorn Autologous Hair Follicle Secretome cosmetic product following their medical aesthetic procedures. The procedures involved include laser resurfacing of the face (ablative or non-ablative), Tixel treatment of the face, and treatments for acne and surgery scars combined with ablative or non-ablative laser or microneedling. Some hair-related treatments and procedures are closed to enrollment. The study observes real-world usage without intervening in treatment decisions. During the study, participants will be monitored for symptoms and downtime related to their procedures over a period of 1 to 7 days. Researchers will collect data on post-procedure symptoms and downtime using questionnaires to understand the product's impact as an adjunct to aesthetic procedures. The study ensures safety by excluding participants with conditions that may interfere with participation and by tracking any relevant health status changes throughout the observation period.

Researchers are evaluating the effects of two types of amnion grafts—a tri-layer amnion graft and a single-layer amnion graft—in patients with difficult-to-heal diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter hybrid platform trial compares these treatments to a matched retrospective control group receiving standard care. The study aims to gather real-world evidence to better understand how these grafts perform in everyday clinical settings and to assess their effectiveness alongside standard wound care practices. Participants receive one of two human tissue allografts derived from the amniotic membrane: BioLab Membrane Wrap Lite, a single-layer amnion membrane, or BioLab Tri-Membrane Wrap, a triple-layer amnion-chorion-amnion membrane. Both products serve as wound coverings to support healing. Standard care includes wound debridement, moisture balance management, bacterial burden reduction, offloading, and multilayer compression. The study includes a prospective cohort treated with these grafts and compares them to a retrospective control group matched by clinical factors. During the study, participants are monitored for wound closure over 12 weeks. Assessments include measuring wound size and healing progress compared to standard care alone. Researchers evaluate the clinical effectiveness of the grafts in supporting wound healing. Participants must follow the study protocol and attend scheduled visits, with safety monitored throughout the study. The trial seeks to provide important data on wound healing outcomes in a diverse patient population over the 12-week period.

Researchers are evaluating the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-103 in adolescents and adults aged 12 to 35 years who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b/2a first-in-human clinical trial aims to better understand how CNP-103 affects this population and to monitor any immune-related safety concerns. Participants will receive either CNP-103 or a placebo (0.9% sodium chloride injection) over a 90-day treatment period following a 28-day screening phase. The study includes multiple dose cohorts with weight-based eligibility criteria and requires participants to continue standard diabetes management including insulin therapy, nutrition plans, and exercise as appropriate. After treatment, participants will undergo post-dose evaluations lasting 275 days to monitor long-term safety and effects. Throughout the approximately 393-day study, participants will attend visits for assessments including safety and immune monitoring, pharmacodynamics evaluations, and efficacy measurements. Researchers will closely track adherence to medication and monitor laboratory tests, while safety and immune responses will be evaluated from Day 1 through Day 365. This comprehensive follow-up aims to gather detailed information on the participant's health and response to the investigational treatment over time.

Researchers are studying the real-world use of the Optilume174; BPH Catheter System in men who have symptoms caused by benign prostatic hyperplasia (BPH), which is an enlarged prostate condition. This prospective registry collects information from multiple sites to better understand how this treatment works outside of controlled clinical trials. The study aims to evaluate both the effectiveness and safety of the catheter system in this patient group. The study involves collecting data from men who are undergoing treatment with the Optilume drug-coated catheter system as part of their regular care. No additional experimental treatments or randomization are described, as the focus is on observing patient outcomes with this device during usual medical practice. Participants will be monitored for changes in their urinary symptoms using the International Prostate Symptom Score (IPSS) from the start of treatment to 12 months later. Safety is also tracked by recording any serious adverse events related to the treatment during the same period. Data collection includes patient reports and clinical follow-ups over the course of one year to assess both benefit and safety outcomes.

Researchers are evaluating the safety of two minimally invasive treatments for men with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). The study compares the iTind device, a temporary nitinol implant that reshapes the prostate over 5 to 7 days, with the UroLift system, which permanently places implants to widen the urethra. This post-market, international study aims to directly compare these options in men aged 50 and older with BPH symptoms requiring treatment. Participants will receive either the iTind device, which stays implanted for 5 to 7 days to reshape the prostatic urethra through pressure and tissue remodeling, or the UroLift procedure, which places permanent implants to retract enlarged prostate lobes. The study involves randomization and follows participants after treatment to assess safety and effectiveness. During the study, men will attend scheduled visits to complete questionnaires and undergo tests such as prostate imaging and urinary flow measurements. Researchers will monitor complications occurring during and after the procedures for up to 3 months. Participants must be able to complete all visits and assessments to help evaluate the treatments' safety profiles and effects on urinary symptoms.

Researchers are evaluating the effectiveness and safety of TR987 0.1% gel combined with Standard of Care compared to Standard of Care alone to treat people with non-healing Venous Leg Ulcers (VLUs). This Phase 3 outpatient study is randomized, double-blind, and conducted across multiple centers over 16 weeks. The main goal is to see how many participants achieve complete closure of their target ulcer by the end of treatment at 16 weeks. Additional goals include measuring sustained healing at 3 months, pain reduction, and changes in ulcer size. Participants are randomly assigned to one of two groups: one group receives TR987 0.1% topical gel plus Standard of Care, which includes wound cleansing, dressings, and compression bandaging; the other group receives Standard of Care alone. The study lasts for 16 weeks, with treatment and monitoring occurring throughout this period. Safety and supplementary outcomes are also assessed during the trial. During the study, participants attend scheduled visits for evaluations that include measuring ulcer size and monitoring pain levels. Researchers track healing progress and collect safety data. The primary outcome is the proportion of participants whose target ulcer fully closes by week 16. Follow-up assessments at 3 months after healing help confirm the durability of ulcer closure. Total participation spans the 16-week treatment period plus follow-up evaluations.