optilume clinical trial

"The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn't surgically cut, burn . Last 3 Days. , Inc., headquartered in Plymouth, Minnesota, is a clinical-stage medical device company currently conducting clinical trials to support global commercialization of their products. . The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The purpose of the study is to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH). These subjects will be treated with the Optilume BPH Catheter System. hemoglobin A1c ≥ 8%), History of clinically significant comorbidities or presence of unstable conditions [e.g. This is a highly accessible and practical guide to all urologic cancers. With a strong emphasis on best practice management choices, the book is ideal for the general urologist wishing to treat cancer patients with optimum effect. BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). Minnesota, is a clinical-stage medical device company currently conducting clinical trials to support global commercialization of their products. The IDE clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. Optilume may serve as an important alternative for men with recurrent strictures that want to avoid or delay urethroplasty".4, David Perry, President and CEO of Urotronic, Inc. stated, "We are excited to introduce Optilume to the US urology community and their patients who suffer from this debilitating disease. . The Optilume® Drug Coated Balloon is a novel, minimally invasive technology for the treatment of urethral stricture. . At Screening (Visit 1), subjects will enter . Urotronic, Inc., headquartered in Plymouth, Minnesota, is a medical device company currently conducting clinical trials to support global commercialization of their products. Early data in clinical trials of the Optilume ® Drug Coated Balloon are very encouraging, with a reported 81% of patients free from repeat intervention, including self-catheterization, at 24 months 3. The Optilume drug-coated balloon is an exciting innovation in urethral stricture treatment—giving patients and physicians an effective solution that can deliver + \ +. Omschrijving: The Optilume Drug Coated Balloon (DCB) is a . Longer term comparison study data is expected to be published in the future which will determine the long-term efficacy of the technology versus . The Optilume BPH Catheter System is an investigational device, not available for sale in the U.S. CAUTION- Investigational Device. LABORIE secures option to acquire Urotronic's Optilume™ technology. A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH, Experimental: Optilume™ BPH Catheter System, Experimental: Pharmacokinetics Optilume Arm, 50 Years to 80 Years   (Adult, Older Adult), Urological Associates of Southern Arizona, PC, Little Rock, Arkansas, United States, 72211, Daytona Beach, Florida, United States, 32114, Lake Barrington, Illinois, United States, 60010, Shreveport, Louisiana, United States, 71106, Englewood, New Jersey, United States, 07631, Cheektowaga, New York, United States, 14225, Garden City, New York, United States, 11530, Manhattan Medical Research Practice, PLLC, Raleigh, North Carolina, United States, 27612, Myrtle Beach, South Carolina, United States, 29572, University of Montreal Hospital Center (CHUM). ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device. Optilume works by inhibiting new scar tissue growth that often recurs after endoscopic dilations. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Last 14 Days. The U of U Health is the only academic medical center in the Mountain West, providing exceptional patient care alongside quality teaching and research in an effort to bring the latest medical advancements to the bedside. This book addresses issues and highlights recent advances in the use of biodegradable polymers. The Guidelines for the Blood Transfusion Services in the UK - known affectionately as the Red Book is the result of a collaboration between the four national services of the UK Blood Transfusion Service (UKBTS), and the National Institute ... This book aims to shed light on some of the unexplored aspects of biomedical science and the recent researches in this field. Optilume is the treatment that breaks the cycle of recurrent urethral strictures." Optilume procedure is well tolerated by patients and has shown promising early data in clinical trials.5 Paclitaxel is a proven antiproliferative drug that has been used in chemotherapy since the early 1990's and percutaneous coronary interventions since 2004. A text on the use of bleaching in the practice of esthetic dentistry. Urotronic has ongoing trials designed to support US FDA approval of Optilume for patients with urethral strictures. The Optilume BPH Catheter System is a novel Minimally Invasive Surgical Therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Talk with your doctor and family members or friends about deciding to join a study. Heyns CF, Steenkamp JW, De Kock MLS, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? This book outlines developments in all areas of urological cancer, bringing together, in one volume, summaries of clinical and molecular advances, which will be invaluable to urologists and oncologists. This innovative technology meets multiple unmet medical needs in the market, expands LABORIE's current urology offering, and aligns well with our desire to help clinicians improve their . . The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The Optilume BPH Catheter System is a novel Minimally Invasive Surgical Therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). finasteride (Proscar, Propecia)] within 3 months of baseline assessment, Use of 5-alpha reductase inhibitor [e.g. Funding Urotronic Inc Clinical Trial Yes Registration Number NCT03499964 RCT Yes . https://optilume.com/, For Further Information: 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation), A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. 2007, May. This Oxford Specialist Handbook is a concise, practical yet comprehensive guide to ophthalmic anaesthesia, covering anatomy, specific anaesthetic techniques and principles, and recent changes in the field. "This book teaches you how to evaluate each patient who walks through your door from the macro to the micro, focusing first on the big picture and then working your way to the minute details in order to treatment plan for the best possible ... . Optilume was granted CE mark approval for use in urethral strictures in 2020. . "Optilume™ is a disruptive, minimally invasive technology that has the potential to change the standard of care for urethral strictures and for BPH. The Optilume drug coated balloon is a "guidewire compatible catheter with a tapered atraumatic tip. . The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH) 3. Commonly known as the Red Book, Guidelines for the Blood Transfusion Services in the United Kingdom 8th Edition contains best practice guidelines for all materials produced by the United Kingdom Blood Transfusion Services (UKBTS) for both ... BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older. consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects). This much-anticipated book presents the procedural phases required to achieve optimal results in the esthetic rehabilitation of patients in need of fixed prostheses. This innovative, proprietary technology represents a significant paradigm change from the methods currently used by urologists to treat these conditions and provides a durable, low-cost, minimally invasive treatment option for millions of patients suffering from these conditions globally. Laborie has a strategic partnership with Urotronic, the company that created Optilume. Found inside – Page 50Reddy reported on 62 patients with moderate to severe BPH who underwent balloon dilation using the AMS Optilume catheter . ... CLINICAL TRIALS REFERENCES Numerous clinical trials of these catheters have been completed or are ongoing . "The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn't surgically cut, burn, lase, steam or leave anything behind in the prostate . Use our useful search tool to learn more different trials and how to participate. duloxetine, imipramine and amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment, Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment, Use of Type II 5-alpha reductase inhibitor [e.g. Funding Urotronic Inc Clinical Trial Yes Registration Number NCT03423979 RCT No Subjects Human Ethics Committee National Council of Bioethics in . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Device: Optilume™ BPH Prostatic DCB Dilation Catheter. Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices. In the ROBUST 1 and ROBUST 3 trials with patients who had received multiple prior dilations, there were: No device-related serious complications* Thoroughly revised and updated, this edition includes more terms, more pronunciations, and extensive appendices for quick, easy-to-use access to information used daily in the clinical setting. Full-color illustrations enhance definitions. Interventional (Clinical Trial) Estimated Enrollment : 500 participants: Allocation: Randomized: Intervention Model: Crossover Assignment: Intervention Model Description: Randomized study with a non-randomized, Pharmacokinetics arm. Subjects randomized to the Control arm are allowed to crossover to the Test arm if they meet the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. . Study primarily outcomes are measured by 1). The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. 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