Bioresorbable Scaffolds: From Basic Concept to Clinical ... Drug-coated balloon found efficacious for strictures A text on the use of bleaching in the practice of esthetic dentistry. In October 2020, Laborie and Urotronic Inc. (Urotronic), entered into a multi-faceted, strategic partnership1. So compared to historical controls, the Optilume performed well," Dr. Elliott told Urology Times. Looks: Why They Matter More Than You Ever Imagined For more information on Urotronic and our products, please visit us at urotronic.com or Optilume.com. ", https://www.prnewswire.com/news-releases/fda-approves-optilume-urethral-drug-coated-balloon-a-breakthrough-treatment-for-urethral-strictures-301442655.html. This book is the result of the 21st Study Group, which was held in October 1989. The participants included urological and colorectal surgeons and a neurologist, as well as scientists and gynaecologists. Funding Urotronic Inc Clinical Trial Yes Registration Number NCT03499964 RCT Yes . Urologists have long used mechanical dilation, but many men end up needing a . A urethral stricture is a scar in or around the urethra that can restrict the flow of urine from the bladder and can result in a painful, frustrating slowing of the urinary stream. This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. The Global Patient Safety Challenge, brings together the expertise of specialists to improve the safety of care. The area chosen for the first Challenge in 2005-2006, was infection associated with health care. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. You have reached the maximum number of saved studies (100). Listing a study does not mean it has been evaluated by the U.S. Federal Government. Clinical Trial on Urethral Stricture: Optilume Drug Coated ... The technology combines balloon dilation, to expand or widen the strictured area, with delivering an anti-proliferative drug (paclitaxel) to reduce stricture recurrence. Optilume™ BPH Prostatic Drug Coated Balloon Dilation ... The Optilume drug coated balloon is a "guidewire compatible catheter with a tapered atraumatic tip. The early feasibility study will be conducted at 5 medical centers around the country including the University of Iowa, University of . For general information, Learn About Clinical Studies. Early efficacy results are encouraging and support further followup of these men through five years, as well as further inves-tigation with a randomized trial. 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. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume, Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ], Major Device Related Serious Complications [ Time Frame: 12 months ], Male subject 50-80 years of age who has symptomatic BPH, International Prostate Symptom Score (IPSS) ≥ 13, Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml), Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS), Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS, History of inadequate response, contraindication, or refusal of BPH medical therapy, Able to complete the study protocol in the opinion of the investigator, Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements, Unwilling to abstain or use protected sex for the first 30 days post treatment, Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure, Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate, Any prior minimally invasive intervention (e.g. In this second edition of a work on improving the appearance of patients' teeth, there are new sections on bleaching, porcelain laminates, porcelain inlays/onlays, resin-bonded bridges and more. Please remove one or more studies before adding more. The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. The Optilume® Urethral Drug Coated Balloon (DCB) is a urethral dilation balloon with a proprietary paclitaxel coating that combines mechanical dilation of the stricture for immediate symptomatic relief with local drug delivery to maintain urethral patency. 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 ... For general information, Learn About Clinical Studies. (Clinical Trial), treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter, Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia, Experimental: Optilume™ BPH Prostatic DCB Dilation Catheter, 50 Years and older (Adult, Older Adult), Santiago De Los Caballeros, Santiago, Dominican Republic, Santo Domingo Oeste, Santo Domingo, Dominican Republic, Panama City,, Urbanización Marbella Ciudad De Panamá, Panama. - Optilume® is an effective alternative to traditional endoscopic stricture treatments for male urethral strictures, offering minimally invasive, immediate relief, - This breakthrough treatment dilates the urethral lumen and delivers paclitaxel directly to the stricture, significantly reducing the incidence of stricture recurrence.1. Introduction Optilume ® combines balloon . Urotronic, Inc., headquartered in Plymouth, Minnesota, is a medical device company currently conducting clinical trials to support global . consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects). The post-treatment follow-up visit can be up to 5 years. In clinical trials performed in Latin America, the drug-coated balloon has performed as intended in both opening blockages and preventing the formation of scar tissue which can develop . intravesical prostatic protrusion (IPP) > 1 cm], Device that corresponds with the subject's prostate size is not available, Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study, In the opinion of the investigator, it is not in the subject's best interest to participate in the study. - Laborie Medical Technologies Inc. signed a definitive agreement today and entered into a multi-faceted, strategic partnership with Urotronic Inc. (Urotronic), a Minnesota-based medical device company currently conducting clinical trials to support regulatory approval of Optilume™, FDA Approves Optilume® Urethral Drug Coated Balloon, a breakthrough treatment for urethral strictures - read this article along with other careers information, tips and advice on BioSpace . Dr. R. Robert Dhir of HTX Urology in Webster, Texas, is set to use the Optilume BPH catheter system after a previous clinical study of 80 men who suffered from moderate-to-severe lower urinary tract symptoms caused by BPH found that patient quality of life symptom scores improved by more than 60% at the three-month mark and were sustained . This book focuses on the coronary bioresorbable scaffold, a new interventional treatment for coronary artery disease, differentiated from a permanent metallic stent. Santucci, RA Male Urethral Stricture Disease J Urol. Participating in This Clinical Trial Inclusion Criteria 1. Last 3 Days. SchornI@urotronic.com. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study; In the opinion of . In this book the authors explore the state of the art on efficiency measurement in health systems and international experts offer insights into the pitfalls and potential associated with various measurement techniques. The EVEREST-1 Optilume pilot trial that preceded the PINNACLE trial enrolled 80 men with BPH across 6 investigational sites in Latin America. .
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