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Biopsy Tract Sealing Device with Magnetic Resonance and X-Ray Image Contrast

Award Number: R01CA254964
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2021
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Biopsy Tract Sealing Device with Magnetic Resonance and X-Ray Image Contrast - PROJECT SUMMARY When cancer is suspected in a patient, the tissue in question must be removed and analyzed. This procedure is called a biopsy and is a crucial step in early detection of cancer. However, the procedure leaves a hole in the tissue which can continue to bleed, or in the case of lung tissue, leak air. In order to prevent any complications, we propose a new device to fill these tissue voids that addresses limitations of current technologies. The Biopsy Tract Sealing Device will be made of a shape memory foam and a gel that expand to fill the void made during biopsy. The device will seal the hole to prevent any leaks of air or blood, with an added benefit of being visible under MRI and X-ray imaging. This feature allows the physician to monitor any disease progression at the biopsy site in follow-up visits. The proposed work includes extensive pre-clinical testing and design verification that is required to translate this technology. Namely, we plan to: 1) finalize design of the device, 2) perform studies to confirm the devices are non-toxic and do not cause any undesirable tissue reaction after implantation, 3) conduct device design verification tests to ensure performance is successful, and 4) summarize all test results in reports that can later be used in an application to the Food and Drug Administration (FDA). This proposal has the potential to improve the safety and utility of a common procedure that can save lives through early detection of cancer. Approximately 140,000 lung biopsies and 110,000 liver biopsies are performed in the US each year. With high complication rates (~20-50%) of lung biopsy procedures and risk of severe bleeding complications with liver biopsies, the healthcare of thousands of patients will be improved by this device development.


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: 2026 ( Subtotal = -$14,742 )
2026	2024	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	Cancer Detection and Diagnosis Research	000	4	6/2/2026	NON-COMPETING CONTINUATION	-$14,742
														Subtotal = -$14,742

Issue Date FY: 2024 ( Subtotal = $575,248 )
2024	2024	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	Cancer Detection and Diagnosis Research	001	4	4/22/2024	NON-COMPETING CONTINUATION	$30,278
2024	2024	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	Cancer Detection and Diagnosis Research	000	4	12/22/2023	NON-COMPETING CONTINUATION	$544,970
														Subtotal = $575,248

Issue Date FY: 2023 ( Subtotal = $598,229 )
2023	2023	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	Cancer Detection and Diagnosis Research	000	3	1/30/2023	NON-COMPETING CONTINUATION	$598,229
														Subtotal = $598,229

Issue Date FY: 2022 ( Subtotal = $595,333 )
2022	2022	TEXAS A&M ENGINEERING EXPERIMENT STATION	3124 TAMU	COLLEGE STATION	TX	77843	BRAZOS	USA	Cancer Detection and Diagnosis Research	001	2	6/23/2022	NON-COMPETING CONTINUATION	$48,599
2022	2022	TEXAS A&M ENGINEERING EXPERIMENT STATION	7607 EASTMARK DR	COLLEGE STATION	TX	77840	BRAZOS	USA	Cancer Detection and Diagnosis Research	000	2	1/7/2022	NON-COMPETING CONTINUATION	$546,734
														Subtotal = $595,333

Issue Date FY: 2021 ( Subtotal = $639,391 )
2021	2021	TEXAS A&M ENGINEERING EXPERIMENT STATION	7607 EASTMARK DR	COLLEGE STATION	TX	77840	BRAZOS	USA	Cancer Detection and Diagnosis Research	000	1	2/5/2021	NEW	$639,391
														Subtotal = $639,391

Grand Total All Awards = $2,393,459

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Biopsy Tract Sealing Device with Magnetic Resonance and X-Ray Image Contrast

Award Number: R01CA254964

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/15/2021

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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