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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DK117813-06
Agency Tracking Number: R44DK117813
Amount: $752,597.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA21-260
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2025-08-31
Small Business Information
310 ROLLING RIDGE DR
Bellefonte, PA 16823-8445
United States
DUNS: 791379030
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 MAUREEN MULVIHILL
 (814) 355-0003
 maureen.mulvihill@actuatedmedical.com
Business Contact
 MAUREEN MULVIHILL
Phone: (814) 355-0003
Email: maureen.mulvihill@actuatedmedical.com
Research Institution
N/A
Abstract

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 rt 80,000 deaths and $20B in healthcare costs in the U.S. annually. Clinicians struggle to safely
resect large (rt2 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 lt2 cm polyps to 85% for polyps rt2 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
(VandV) and FDA 510(k) Submission. Acceptance Criteria: All tests passed in VandV. FDA 510(k) for Upper GI
model. Aim 3: GripTract Lower GI Model Clinical Preparation and 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.

* Information listed above is at the time of submission. *

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