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Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

Award Number: R44AG034714
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2009
PERIOD OF PERFORMANCE END DATE: 04/30/2016

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Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment - DESCRIPTION (provided by applicant): Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women, however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology founded on the principles similar to those of manual palpation. In Phases I and II we designed and built a and prototypes of VTI with tactile sensor array and a motion tracking sensor, completed VTI testing and verification with the tissue mimicking phantoms, completed Phase I and initiated Phase II clinical study. Clinical results demonstrated capability of the proposed approach for 3-D imaging of the vagina and pelvic floor support structures. Our findings suggest that the normality ranges for tissue elasticity of vagina and its support structures evaluated by VTI might be used as the markers in diagnosis of pelvic floor conditions. We further demonstrated VTI capability in characterization of outcome of pelvic floor reconstructive surgery. Tactile Imaging technology developed at Artann Laboratories is highly innovative and unique. Artann scientists are the first in the world to introduce and develop Tactile Imaging technology into the practical and proven successful applications described in numerous publications and 21 issued patents. The main goal of Phase IIB is to transform the Phase II VTI ¿-prototype into medical device ready for regulatory review and commercialization. Upon completion of regulatory compliance testing, verification and clinical validation of the VTI, technical and clinical files will be prepared for FDA application. The endpoint for the Phase IIB of the project is the FDA 510(k) submission. The VTI commercialization will follow the FDA approval. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2014	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	085303302	HUNTERDON	USA	Aging Research	000	5	3/30/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $682,065 )
2014	2014	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	000	5	7/10/2014	NON-COMPETING CONTINUATION	$653,710
2014	2014	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	001	5	8/11/2014	NON-COMPETING CONTINUATION	$28,355
														Subtotal = $682,065

Issue Date FY: 2013 ( Subtotal = $828,041 )
2013	2013	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	001	4	8/28/2013	COMPETING CONTINUATION	$828,041
2013	2012	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	000	3	8/26/2013	NON-COMPETING CONTINUATION	$0
														Subtotal = $828,041

Issue Date FY: 2012 ( Subtotal = $574,966 )
2012	2012	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	002	3	3/23/2012	NON-COMPETING CONTINUATION	$93,490
2012	2012	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	000	3	2/6/2012	NON-COMPETING CONTINUATION	$408,612
2012	2012	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	003	3	4/5/2012	NON-COMPETING CONTINUATION	$35,147
2012	2011	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	001	2	3/23/2012	COMPETING CONTINUATION	$37,717
														Subtotal = $574,966

Issue Date FY: 2011 ( Subtotal = $526,726 )
2011	2011	ARTANN LABORATORIES	1753 LINVALE-HARBOURTON RD	LAMBERTVILLE	NJ	08530	HUNTERDON	USA	Aging Research	000	2	2/14/2011	COMPETING CONTINUATION	$526,726
														Subtotal = $526,726

Grand Total All Awards = $2,611,798

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Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

Award Number: R44AG034714

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2009

PERIOD OF PERFORMANCE END DATE: 04/30/2016

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