Clinical readiness of Uzap - the minimally invasive Overactive Bladder treatment

Uzap 的临床准备 - 膀胱过度活动症的微创治疗

基本信息

批准号：
10385026
负责人：
Roger Stern
金额：
$ 25.55万
依托单位：
STELLARTECH RESEARCH CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-20 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10385026
关键词：
Ablation Acute Adult Affect Agonist Animals Arousal Attenuated Bladder Bladder Tissue Bladder mucosa Botulinum Toxins Catheters Cells Clinical Clinical Trials Collaborations Connexins Cost Savings Development Devices Dimensions Documentation Dose Economic Burden Electrodes Engineering Family suidae Female Fibrosis Financial cost Functional disorder Future Gap Junctions Grant Granulation Tissue Health behavior Healthcare Systems Histologic Histology Implant Incontinence Infiltration Inflammatory Injections International Intervention Investigation Legal patent Lesion Life Measurement Mechanics Medical Device Miniature Swine Modality Modeling Mucous Membrane Operative Surgical Procedures Overactive Bladder Patients Pattern Pharmacologic Substance Pharmacotherapy Phase Population Preparation Procedures Radiofrequency Interstitial Ablation Readiness Recording of previous events Refractory Research Research Personnel Residual state Risk Management Safety Sleep Source Specimen Spinal cord injury Structure Symptoms System Testing Therapeutic Therapeutic Intervention Thermal Ablation Therapy Tissue Model Tissues Ultrasonics United States Urination Urodynamics Urologist Work animal safety awake base commercialization cost cost estimate design efficacy study exhaustion experience first-in-human human study implantation improved in vivo innovation interstitial cell medication compliance meetings minimally invasive neoplastic non-drug operation performance tests porcine model preclinical efficacy preclinical safety preservation psychosocial radio frequency reduce symptoms response safety study safety testing side effect usability verification and validation

项目摘要

Abstract Overactive bladder (OAB) severely impacts over 12% of the adult population in the United States – roughly 30 million people (Irwin, et al., 2006). Pressing and frequent urges to urinate, arousal from sleep, and sometimes incontinence, result in immense psychosocial and financial costs, leading to an estimated annual economic burden of >$70B in the US alone (Reynolds, et al., 2016). Current OAB interventions are varied and include pharmaceuticals, neurostimulators, botulinum toxin injections, and surgical approaches, all of which have adverse side effects and lack widespread and enduring efficacy. In addition, drug therapies require long-term dosing and other treatments can require repeat clinical interventions. Stellartech Research Corporation is developing the NewUro Uzap device for transurethral radiofrequency mucosal partitioning. It is the only minimally-invasive, single-session, non-drug, non-implant therapy for alleviating the symptoms of OAB without compromising voiding function. Research has shown excessive electrical connectivity within the bladder mucosa in models of overactivity (Kanai et al., 2007). This results in exaggerated propagation of wave-like intrinsic electrical and mechanical activity, which is anticipated to be amenable to therapy by minimally invasive thermal ablation of mucosal isolation lines by the Uzap. The innovations behind the Uzap system are already covered by 7 granted patents. Preliminary studies of Uzap ablation on whole pig bladder and tissue specimens demonstrated reduced contractile response to agonists. Successful preclinical safety and performance tests were completed in ex vivo and preliminary in vivo porcine models. This Fast-Track proposal seeks, in Phase 1, to demonstrate long-term in vivo safety and durability of Uzap therapy, and, in Phase 2, to 1) perform a long-term animal safety and efficacy study; 2) optimize system and electrode design and usability and fabricate Verification and Validation units; 3) perform Verification and Validation tests; hold a pre-IDE (Investigational Device Exemption) meeting and submit an IDE application for a future First-In- Human trial of 30 female patients with refractory overactive bladder with incontinence. The rigorous work proposed will create a firm base for advancing the Uzap to the clinical phase and towards commercialization, in order to provide relief for millions of patients and eliminate the need for implants or repetitive clinical interventions.

抽象的过度活跃的膀胱（OAB）严重影响了美国12％以上的成年人口 - 大约3000万人（Irwin等，2006）。紧迫并经常敦促小便，唤醒由于睡眠，有时甚至是尿失禁而导致巨大的社会心理和经济成本，仅在美国，估计的年度经济燃烧估计为70B美元（Reynolds等， 2016）。当前的OAB干预措施是多种多样的，包括药物，神经刺激剂，肉毒杆菌毒素注射和手术方法，所有这些都有不良副作用，并且缺乏宽度和持久效率。此外，药物疗法需要长期给药，其他治疗可能需要重复临床干预措施。 Stellartech Research Corporation正在开发用于尿道尿道的Newuro Uzap设备射频粘膜分配。它是唯一的微创，单节，非药物，非植入疗法用于减轻OAB症状而没有损害功能的症状。研究表明，在Blader Mucosa内的电气连通性过多过度活动（Kanai等，2007）。这导致波浪样固有的夸大传播电气和机械活动，预计可通过最低限度地接受治疗 UZAP浸泡粘膜隔离线的侵入性热消融。 UZAP背后的创新系统已经由7项授予专利涵盖。整体上乌扎普消融的初步研究猪膀胱和组织标本表现出对激动剂的收缩反应减少。成功的临床前安全和性能测试在离体中完成，并在体内猪模型。在第1阶段，这项快速曲目提议寻求长期证明乌扎普治疗的体内安全性和耐用性，在第2阶段至1）进行长期动物安全和效率研究； 2）优化系统和电极设计以及可用性和制造验证和验证单位； 3）执行验证和验证测试；持有前读（调查设备豁免）会议并提交IDE申请 30例女性患者患有尿失禁过度活跃的膀胱症患者的人体试验。这拟议的严格工作将创建一个固件基础，以将UZAP推进到临床阶段和朝商业化，为了减轻数百万患者的救济并消除了需求用于关注或重复的临床干预措施。