Minimally Invasive High Intensity Ultrasound Treatment of Uterine Fibroids

Information

  • Research Project
  • 8900205
  • ApplicationId
    8900205
  • Core Project Number
    R44CA121740
  • Full Project Number
    5R44CA121740-03
  • Serial Number
    121740
  • FOA Number
    PA-13-234
  • Sub Project Id
  • Project Start Date
    2/1/2006 - 18 years ago
  • Project End Date
    7/31/2017 - 6 years ago
  • Program Officer Name
    NARAYANAN, DEEPA
  • Budget Start Date
    8/1/2015 - 8 years ago
  • Budget End Date
    7/31/2017 - 6 years ago
  • Fiscal Year
    2015
  • Support Year
    03
  • Suffix
  • Award Notice Date
    7/13/2015 - 8 years ago

Minimally Invasive High Intensity Ultrasound Treatment of Uterine Fibroids

DESCRIPTION (provided by applicant): Benign uterine tumors (fibroids) are clinically apparent in up to 50% of women and typically require surgical removal of symptomatic fibroids or hysterectomy. Treatment options for women considering bearing children are limited to the invasive surgical open myomectomy to best maintain structural integrity of the uterine wall; the less invasive laparoscopic removal is contraindicated. There remains a substantial clinical need for a minimally-invasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations using minimally-invasive thermal ablation (e.g., RF, laser, cryotherapy, HIFU) have demonstrated significant potential in reducing fibroid volume and providing symptomatic relief. Limitations of these techniques include an inability to spatially control the distribution f energy to conform to the fibroid volume, inadequate single treatment volumes requiring multiple device insertions, long procedural times, or use may be limited by the proximity of a fibroid to critical tissue structures (e.g., bladder, bowel). High-intensity interstitial ultrasound devices fr volumetric fibroid ablation have been developed in a Phase I project, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, enhanced radial thermal penetration, and fast heating times. This ultrasound technology can provide a superior minimally-invasive technique for volumetric ablation treatment of uterine fibroids with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., bladder, bowel), accessibility to a larger number of fibroids, and faster procedure times. The objective of this Phase II research & commercialization plan is to finalize development of laparoscopic and transcervical conformal high-intensity interstitial ultrasound devices and spatial control capabilities specific for conformal thermal ablation of large volumes required for successful treatment, with complete delivery system and treatment strategies, specific to precision image-guided volumetric fibroid ablation and approved for clinical study.

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R44
  • Administering IC
    CA
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    640042
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    395
  • Ed Inst. Type
  • Funding ICs
    NCI:640042\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ACOUSTIC MEDSYSTEMS, INC.
  • Organization Department
  • Organization DUNS
    606222896
  • Organization City
    Savoy
  • Organization State
    IL
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    618749510
  • Organization District
    UNITED STATES