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Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

Award Number: R44DK117813
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps - This SBIR Phase IIB project expands the GripTract product line to include a model for upper gastrointestinal (GI) endoscopy procedures and conducts clinical trials in the lower GI at Columbia University and Cleveland Clinic. A preclinical study of the lower GI model in the corresponding Phase II project demonstrated: (a) fewer perforations, (b) lower procedure time, and (c) lower learning curve than control. GripTract is a press-cap on the distal end of the endoscope, with integrated fingers connected to proximal controls. It allows a clinician to manipulate tissue during complex polypectomies without occupying the endoscope’s working channel. Public Health Problem: Cancers of the GI tract accessible by endoscope – esophagus, stomach, and intestines – account for > 80,000 deaths and $20B in healthcare costs in the U.S. annually. Clinicians struggle to safely resect large (>2 cm), complicated polyps (e.g., flat sessile lesions) prone to recurrence and malignancy. Recurrence rates of standard piecemeal resection, which are associated with residual polyp and risk of reseeding of malignant lesions, increase from 3% for <2 cm polyps to 85% for polyps >2 cm. In one Japanese study, endoscopic submucosal dissection (ESD) enabled en bloc removal of large polyps in 84-95% of cases and had a low 0-2% tumor recurrence rate. Difficulty retracting tissue is a significant factor impeding widespread use of ESD. The few available retraction products are expensive, difficult to use, may require a special endoscope, or may not work in all GI regions. GripTract is a cost-effective endoscopic accessory that allows less experienced clinicians to learn ESD more quickly. This will enable wider adoption of ESD, reducing the number of patients having invasive surgical or piecemeal resection, and reducing morbidity and recurrence. Phase IIB Hypothesis: En bloc resection offers high curative and low recurrence rates. By reducing the procedure time, the learning burden, and the incidence of adverse event (AEs), GripTract will enable more physicians to deliver better treatment (en bloc resection) at lower cost. Aim 1: GripTract Upper GI Model Development. Acceptance Criteria: Upper GI Model that fits gastroscopes with distal end diameters 8.9- 10.5 mm and lengths from 1030-1100 mm. Aim 2: GripTract Upper GI Model Verification and Validation (V&V) and FDA 510(k) Submission. Acceptance Criteria: All tests passed in V&V. FDA 510(k) for Upper GI model. Aim 3: GripTract Lower GI Model Clinical Preparation & Ex Vivo/In Vivo Training. Acceptance Criteria: All devices produced for training and clinical studies. IRB submission and approval at clinical sites for the FDA- cleared Lower GI GripTract models. At each site, Clinicians (3/3) meet training specifications (i.e., resection and perforation criteria) with at least 4 resections each in ex vivo and in vivo preclinical models in preparation for the clinical study. Aim 4: Grip-Tract Lower GI Model Multi-site Randomize Clinical Study. Acceptance Criteria: GripTract successfully demonstrates defined endpoints related to safety, dissection duration/speed, and clean resection margins in statistically powered clinical study. GripTract to Standard ESD cost comparison.


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: 2024 ( Subtotal = $804,004 )
2024	2024	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	8/28/2024	NON-COMPETING CONTINUATION	$804,004
														Subtotal = $804,004

Issue Date FY: 2023 ( Subtotal = $1,649,537 )
2023	2023	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	7	9/6/2023	NON-COMPETING CONTINUATION	$1,354,672
2023	2022	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	6	9/1/2023	COMPETING CONTINUATION	$0
2023	2022	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	3/6/2023	COMPETING CONTINUATION	$294,865
2023	2020	ACTUATED MEDICAL, INC.	320 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	6/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,649,537

Issue Date FY: 2022 ( Subtotal = $752,597 )
2022	2022	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	9/22/2022	COMPETING CONTINUATION	$752,597
														Subtotal = $752,597

Issue Date FY: 2021 ( Subtotal = $55,369 )
2021	2020	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	8/4/2021	NON-COMPETING CONTINUATION	$0
2021	2020	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	6/23/2021	NON-COMPETING CONTINUATION	$0
2021	2019	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	3/3/2021	EXTENSION WITH OR WITHOUT FUNDS	$55,369
														Subtotal = $55,369

Issue Date FY: 2020 ( Subtotal = $395,980 )
2020	2020	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/17/2020	NON-COMPETING CONTINUATION	$395,980
														Subtotal = $395,980

Issue Date FY: 2019 ( Subtotal = $833,231 )
2019	2019	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/2/2019	EXTENSION WITH OR WITHOUT FUNDS	$833,231
2019	2018	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/4/2019	NEW	$0
														Subtotal = $833,231

Issue Date FY: 2018 ( Subtotal = $265,113 )
2018	2018	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	8/8/2018	NEW	$0
2018	2018	ACTUATED MEDICAL, INC.	310 ROLLING RIDGE DR	BELLEFONTE	PA	16823	CENTRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/7/2018	NEW	$265,113
														Subtotal = $265,113

Grand Total All Awards = $4,755,831

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Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

Award Number: R44DK117813

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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