Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor
Ended Project Grant Awarded Last action
- Award ID
- R44HD097805
- Recipient
-
Advanced Tactile Imaging Inc. UEI H97VG2NZKLK5
- Awarding agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,195,893
Award facts
- Assistance listing
- 93.865 Child Health and Human Development Extramural Research
- Completion date
- Originally
- Funding
-
- $3,357,112.00 Federal
- $838,781.00 Non-federal
- Place of performance
- New Jersey, USA
Award details come from USAspending.gov.
Description
- Abstract
- Pelvic organ prolapse (POP) is a highly prevalent condition affecting 40-50% of women in the US during their lifetimes. Urinary incontinence (UI) affects up to 48% of women. Both POP and UI are more common in women than in men, and their prevalence is increased with age. Beyond the physical and the quality of life impacts, these conditions cause significant morbidity. The true etiology of POP and UI and their variations observed among individuals is not entirely understood. These disorders are thought to share common pathogeneses, weakening (elasticity changes) of the connective support tissues and pelvic floor muscle dysfunction. The lifetime surgery risk for either UI or POP in women is about 20% by the age of 80 years. A POP surgical failure rate of 61.5% for uterosacral ligament suspension and 70.3% for sacrospinous ligament fixation groups in a representative study was reported. Substantial improvement is possible if patients with the diseased pelvic floor conditions undergo imaging and biomechanical diagnostic tests; the results of which could be FED into a patient-specific optimal treatment. In the phase i research, a conceptual a-prototype of a vaginal tactile and ultrasound imaging probe was designed and its imaging performance demonstrated in a pilot study. Tactile (stress) and ultrasound (anatomy, strain) image fusion furnishes new insights into the female pelvic floor conditions through biomechanical mapping in multiple tests. In phase II, we will design and build a pre- production SS-prototype of a vaginal tactile ultrasound imager (tiusv), which will incorporate the phase i lessons in product development process. We will verify IT via bench testing, validate IT in a multi-site clinical study, prepare and submit a 510(k) application to the FDA.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | $33,438 | $0 | |
| Amendment | $33,438 | $0 | |
| Amendment | $806,337 | $0 | |
| Amendment | $806,337 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $838,781 | $0 | |
| Original award | $838,781 | $838,781 |
Quick answers
Who received award R44HD097805?
R44HD097805 was awarded to Advanced Tactile Imaging Inc. by National Institute of Child Health and Human Development (National Institutes of Health) on February 8, 2019.
How much is award R44HD097805 worth?
$4,195,893 has been obligated on R44HD097805: $3,357,112 in federal funding and $838,781 in non-federal funding.
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