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A tethered capsule endoscopic-endomicroscopic (TEEM) approach for improving upper GI tract diagnosis

Award Number: R01DK117236
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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The diagnosis of most upper GI tract conditions is currently accomplished by upper endoscopy with biopsy (EGD). EGD is costly primarily because it requires conscious sedation, necessitating that procedures be conducted by physicians in a specialized endoscopy suite, and that patients take time away from work and family. Another limitation is sampling error - endoscopic biopsies are frequently random, resulting in many instances of missed disease. Methods such as unsedated transnasal endoscopy (uTNE) have been proposed to decrease the cost of EGD. While in principle uTNE techniques could be used in most cases, physician- associated expense, poor patient acceptance, and an inability to obtain adequate biopsies have hampered its adoption. As a result, there remains an unmet clinical need for an unsedated, less expensive, and more accessible technique that could supersede diagnostic EGD. In this grant, we will develop a replacement for diagnostic EGD that combines video endoscopy with cellular- resolution in vivo microscopy in a swallowable, tethered capsule. Once swallowed, the tethered capsule endoscopy-endomicroscopy (TEEM) device will acquire wide area white light and microscopic images of the esophagus, stomach, and duodenum. Because patients will be unsedated, the procedure can be performed by non-physician personnel in an outpatient setting, thereby improving patient tolerance, increasing efficiency, and lowering costs, resulting in better screening and treatment of this important source of mortality/morbidity. In Aim 1, we will develop the TEEM imaging system and capsule that will incorporate a new cross-sectional, 1-µm- resolution imaging modality known as µOCT, a controllable-stiffness and articulating tether that will facilitate navigation of the stomach, side-viewing white light image acquisition, forward-viewing video, and algorithms for registering µOCT and endoscopy imaging data for offline review. In Aim 2, we will conduct a histopathologic correlative biopsy study to determine the accuracy of µOCT for diagnosing the most common upper GI tract diseases. TEEM tolerance, inter/intra-observer variability, and test-retest reproducibility will then be tested in 55 patients to verify that this technology meets the clinical requirements for upper GI tract screening (Aim 3).


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 = $0 )
2024	2022	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	1/31/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $534,368 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	3/29/2022	NON-COMPETING CONTINUATION	$53,437
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	12/22/2021	NON-COMPETING CONTINUATION	$480,931
														Subtotal = $534,368

Issue Date FY: 2021 ( Subtotal = $663,265 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	3/1/2021	NON-COMPETING CONTINUATION	$66,326
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/11/2021	NON-COMPETING CONTINUATION	$596,939
														Subtotal = $663,265

Issue Date FY: 2020 ( Subtotal = $697,488 )
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	2/10/2020	NON-COMPETING CONTINUATION	$69,749
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	1/1/2020	NON-COMPETING CONTINUATION	$627,739
														Subtotal = $697,488

Issue Date FY: 2019 ( Subtotal = $672,012 )
2019	2019	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/28/2019	NEW	$672,012
														Subtotal = $672,012

Grand Total All Awards = $2,567,133

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A tethered capsule endoscopic-endomicroscopic (TEEM) approach for improving upper GI tract diagnosis

Award Number: R01DK117236

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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