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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: 4R44DK117813-02
Agency Tracking Number: R44DK117813
Amount: $1,229,211.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA17-302
Timeline
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-02
Award End Date (Contract End Date): 2021-01-31
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

The SBIR Fast-track develops, tests, and commercializes the ‘Active Disposable Cap for Endoscope (ACE) Tip
Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps.’ The disposable system
includes a distal-connecting cap, allowing a clinician to manipulate tissue and perform targeted aspiration
during complex polypectomies using proximal controls, without occupying the endoscopic working channel.
Public Health Problem: In the U.S., colorectal cancer is one of the most deadly and costly forms of cancer.
Current endoscopy tools are inadequate to consistently enable full resection of colon polyps. Even polyps andlt;10
mm have an estimated 29% incomplete resection rate. Larger (andgt;2cm), complicated polyps (e.g., flat sessile
lesions) are particularly prone to recurrence and malignancy, impacting patient care and healthcare costs.
Rates of standard piecemeal resection, which is significantly associated with residual polyp, increases from 3%
at andlt;2cm to 85% for polyps andgt;2cm. Endoscopic submucosal dissection (ESD) enabled en bloc removal of andgt;2 cm
polyps in 84-95% of cases, and showed a 0-2% tumor recurrence, in one Japanese study, though this
expertise is limited outside this geographic region. In nearly all other countries, rates of en bloc ESD are well
below 50% - and ESD procedures take over 100 minutes compared to 20-50 minutes for piecemeal resection.
Open surgical resection further increases risks and costs. The goal of this proposed project is allowing a safe
and effective en bloc ESD with full lesion removal to be performed rapidly. Phase I Hypothesis. ACE enables
en bloc resection of large simulated polyps and acceptable forces on tissues in vitro, and demonstrates
improved working capabilities in vivo with any damage to porcine colon limited to the mucosa. Aim 1 – ACE
demonstrates improved polypectomy functionality and demonstrates safety from perforation in bench models.
Acceptance Criteria: Favorable clinician response on ACE capabilities and performance based on 10-point
Likert scale, and ≥75% (18/24) successful en bloc resections of ≥ 2cm, difficult lesions in vitro. Aim 2 –
Confirm safety and efficacy feasibility of ACE in pilot preclinical study. Acceptance Criteria: Pilot in vivo study
(N=3) successfully achieves simulated ≥2cm polyp removal en bloc in porcine model with no significant colon
damage or adverse events at up to 72-hours post-procedure. Phase II Hypothesis. ACE is safe and effective
for improving endoscopic access and stability, and complete lesion removal, during complex polypectomies in
the colon. Aim 3 – Verification and validation to support regulatory submissions. Acceptance Criteria: Pass
acceptance criteria on each individual test. Acceptance criteria are set on an individual test basis using a risk-based
approach. Aim 4 – Demonstrate faster en bloc resection and same or better safety with ACE versus
endoscope-only. Submission of the De Novo premarket application to the FDA. Acceptance Criteria: ACE
reduces en bloc resection procedure time relative to endoscope-only resection (N=16; pandlt;0.05, βandlt;0.1) with the
same or less visual and histological mucosal damage and no adverse events. FDA De Novo submission.Relevance – At least 3.4 million endoscopic polyp removal (polypectomy) procedures are performed in the
U.S. annually as part of a regimen for prevention of colorectal cancer, one of the leading causes of cancerrelated
deaths. In the case of large polyps (≥2cm), the limitations of the endoscope and accessory tools within
the narrow operational field often necessitate either less-desirable piecemeal resection, increasing the risk of
incomplete removal, or open surgical resection referral. The proposed Active Cap System for Endoscopes is a
disposable accessory device that enables physician-controlled tissue manipulation and aspiration during
polypectomy without occupying the working channel of the endoscope. The goal is to safely reduce procedural
time and the number of open surgery referrals for small or large polyps, while ensuring complete polyp
removal.

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

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