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
- 来源:
- 关键词:AbdomenAcousticsAcuteAddressAdultAffectAmericanAnatomyAnestheticsAnimalsBusinessesCadaverCathetersChildbirthClinicalClinical ResearchCoagulation ProcessCollagenComputer softwareConnective TissueConsultationsDataDevelopmentDevelopment PlansDevice DesignsDevicesDiseaseDoseEnsureEvaluationExerciseExertionExpenditureExtravasationFasciaFemale urethral structureFocused UltrasoundFreedomFreezingFutureGenitourinary systemGoalsHeatingHistologicHistologyHumanImplantIntellectual PropertyLegal patentLicensingLiftingLigamentsMarketingMedicalMental DepressionMental HealthMethodsModelingModificationMorbidity - disease rateMucous MembraneNatural regenerationOperative Surgical ProceduresOutpatientsPalliative CarePatientsPatternPelvic floor structurePelvisPenetrationPerformancePharmacologic SubstancePhasePreparationProceduresRadialReadinessRecoverySafetyScanningSideSterilitySterilizationStress Urinary IncontinenceStructureStudy modelsSurgical incisionsSymptomsSystemTechniquesTechnologyTemperatureTestingTherapeuticTherapeutic InterventionThermal Ablation TherapyTimeTissuesTubular formationUltrasonic TherapyUltrasonographyUrethraUrinary IncontinenceUrineVaginaValidationWomanWomen&aposs HealthWorkalternative treatmentbaseclinical implementationclinical investigationcommercializationcostcost effectivenesscurative treatmentsdesigndosimetryewe modelexperimental studyhealinghuman femalehuman modelhuman subjectimage guidedin silicoin vivoinnovationinterstitialmanufacturing processminimally invasivenew technologypalliativepaymentpersonalized medicinephantom modelphase 2 studypreclinical studypressureprocess optimizationprotocol developmentreduce symptomsresponsesafety studyself esteemside effectsimulationsoft tissuetreatment optimizationtreatment planningtreatment strategyultrasoundurinaryvaginal mucosa
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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{{ 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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