Image-Guided Transurethral HIFU for Genitourinary Therapy

图像引导经尿道 HIFU 泌尿生殖治疗

基本信息

  • 批准号:
    10452639
  • 负责人:
  • 金额:
    $ 46.88万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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

项目成果

期刊论文数量(2)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Everette C Burdette其他文献

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{{ truncateString('Everette C Burdette', 18)}}的其他基金

Image-guided ultrasound ablation for precision targeting of prostate cancer
图像引导超声消融精确靶向前列腺癌
  • 批准号:
    10449277
  • 财政年份:
    2018
  • 资助金额:
    $ 46.88万
  • 项目类别:
Image-guided ultrasound ablation for precision targeting of prostate cancer
图像引导超声消融精确靶向前列腺癌
  • 批准号:
    9757727
  • 财政年份:
    2018
  • 资助金额:
    $ 46.88万
  • 项目类别:
Image-guided ultrasound ablation for precision targeting of prostate cancer
图像引导超声消融精确靶向前列腺癌
  • 批准号:
    10255514
  • 财政年份:
    2018
  • 资助金额:
    $ 46.88万
  • 项目类别:
Image-guided ultrasound ablation for precision targeting of prostate cancer
图像引导超声消融精确靶向前列腺癌
  • 批准号:
    10004592
  • 财政年份:
    2018
  • 资助金额:
    $ 46.88万
  • 项目类别:
Image-Guided Transurethral HIFU for Genitourinary Therapy
图像引导经尿道 HIFU 泌尿生殖治疗
  • 批准号:
    9049577
  • 财政年份:
    2015
  • 资助金额:
    $ 46.88万
  • 项目类别:
Image-Guided Transurethral HIFU for Genitourinary Therapy
图像引导经尿道 HIFU 泌尿生殖治疗
  • 批准号:
    10259640
  • 财政年份:
    2015
  • 资助金额:
    $ 46.88万
  • 项目类别:
Robotic System with Multiplexed DOF Control for Minimally Invasive Interventions
用于微创干预的具有多自由度控制的机器人系统
  • 批准号:
    8253123
  • 财政年份:
    2012
  • 资助金额:
    $ 46.88万
  • 项目类别:
PET-determined prostate brachytherapy dosing using intraoperative image-guidance
使用术中图像引导 PET 确定前列腺近距离放射治疗剂量
  • 批准号:
    9382210
  • 财政年份:
    2010
  • 资助金额:
    $ 46.88万
  • 项目类别:
PET-determined prostate brachytherapy dosing using intraoperative image-guidance
使用术中图像引导 PET 确定前列腺近距离放射治疗剂量
  • 批准号:
    9505848
  • 财政年份:
    2010
  • 资助金额:
    $ 46.88万
  • 项目类别:
PET-determined prostate brachytherapy dosing using intraoperative image-guidance
使用术中图像引导 PET 确定前列腺近距离放射治疗剂量
  • 批准号:
    9924500
  • 财政年份:
    2010
  • 资助金额:
    $ 46.88万
  • 项目类别:

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