Image-Guided Transurethral HIFU for Genitourinary Therapy

图像引导经尿道 HIFU 泌尿生殖治疗

• 批准号: 10452639
• 负责人: Everette C Burdette
• 金额: $ 46.88万
• 依托单位: ACOUSTIC MEDSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-25 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10452639
• 关键词: Abdomen; Acoustics; Acute; Address; Adult; Affect; American; Anatomy; Anesthetics; Animals; Businesses; Cadaver; Catheters; Childbirth; Clinical; Clinical Research; Coagulation Process; Collagen; Computer software; Connective Tissue; Consultations; Data; Development; Development Plans; Device Designs; Devices; Disease; Dose; Ensure; Evaluation; Exercise; Exertion; Expenditure; Extravasation; Fascia; Female urethral structure; Focused Ultrasound; Freedom; Freezing; Future; Genitourinary system; Goals; Heating; Histologic; Histology; Human; Implant; Intellectual Property; Legal patent; Licensing; Lifting; Ligaments; Marketing; Medical; Mental Depression; Mental Health; Methods; Modeling; Modification; Morbidity - disease rate; Mucous Membrane; Natural regeneration; Operative Surgical Procedures; Outpatients; Palliative Care; Patients; Pattern; Pelvic floor structure; Pelvis; Penetration; Performance; Pharmacologic Substance; Phase; Preparation; Procedures; Radial; Readiness; Recovery; Safety; Scanning; Side; Sterility; Sterilization; Stress Urinary Incontinence; Structure; Study models; Surgical incisions; Symptoms; System; Techniques; Technology; Temperature; Testing; Therapeutic; Therapeutic Intervention; Thermal Ablation Therapy; Time; Tissues; Tubular formation; Ultrasonic Therapy; Ultrasonography; Urethra; Urinary Incontinence; Urine; Vagina; Validation; Woman; Women' s Health; Work; alternative treatment; base; clinical implementation; clinical investigation; commercialization; cost; cost effectiveness; curative treatments; design; dosimetry; ewe model; experimental study; healing; human female; human model; human subject; image guided; in silico; in vivo; innovation; interstitial; manufacturing process; minimally invasive; new technology; palliative; payment; personalized medicine; phantom model; phase 2 study; preclinical study; pressure; process optimization; protocol development; reduce symptoms; response; safety study; self esteem; side effect; simulation; soft tissue; treatment optimization; treatment planning; treatment strategy; ultrasound; urinary; vaginal mucosa

Abstract Stress urinary incontinence (SUI) in women is an increase of pelvic floor compliance which results in decreased urethral pressure, typically through childbirth, and presents as urine leakage during abdominal strain. SUI has significant impact on women’s health, including an association with increased levels of depression. Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra. Bulking agents injected in the peri-urethral tissue are a longstanding effective but temporary treatment. Pharmaceuticals are relatively new, prohibitively expensive, and there is no track record of long-term efficacy and negative side effects can occur. Approximately 14 million women are relegated to the palliative approaches of wearing absorptive pads or diapers through the day. A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations of minimally-invasive thermal techniques have demonstrated targeted thermal modification and stiffening of pelvic tissue can reduce symptoms of SUI. These techniques have shown promise, but are more invasive than the current surgical options and are less effective. Our Phase II development study showed encouraging in vivo results suggesting that our innovative therapeutic ultrasound catheter based noninvasive technology can efficiently deliver thermal therapy at the target tissue of endopelvic fascia without damaging surrounding tissue (vaginal and urethal wall), based on histopathological analysis, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, well-controlled radial thermal penetration, and fast treatment times. In comparison to existing thermal approaches, our Phase II results clearly demonstrate a significant advance in technology and approach for treating SUI with the promise of more accurate and thorough targeting of heat-induced collagen regeneration, protection of critical non-targeted tissue (e.g., urethral and vaginalmucosa), short procedure times, and thereby increasing accessibility to a larger number of SUI patients. The objective of this Phase IIB plan is to design-freeze our therapy applicator design and then conduct a GLP in-vivo study with our ultrasound SUI catheter and FDA 510(k) cleared TheraVision® system for data to support a follow-on clinical study under FDA Guidance and to further build additional strong intellectual property around the technology. Market analyses will be conducted to develop strategies leading to commercialization. Device design, bench experiments, biothermal and acoustic modeling, together with experimental testing in both human female pelvis cadaveric studies and an in-vivo GLP compliant study in ewes GU tract, combined with workflow study will be conducted to freeze device design, extensively characterize device performance, and applied to potential treatment approaches in preparation for the ultimate goal of product finalization and clinical implementation. Devices will be manufactured under our existing ISO compliant Quality Management System.

摘要