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Squashing the Scope Superbug: A Disposable System for ERCP that Saves Patients from Bacterial Cross-Contamination

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DK126606-01
Agency Tracking Number: R44DK126606
Amount: $1,157,591.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-08-01
Award End Date (Contract End Date): 2022-07-31
Small Business Information
Nashville, TN 37205-4401
United States
DUNS: 081343728
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (817) 320-3328
Business Contact
Phone: (706) 830-3471
Research Institution

Project Summary/Abstract:
The objective of this proposal is to create a new low-cost, disposable system that enables reliable, safe,
standard endoscopes to replace expensive, customized duodenoscopes, which have recently been shown to
cause infections at an alarming rate.
Clinical significance comes from the fact that 40,000 patients per year will be infected by unclean duodeno-
scopes, among the 700,000/year who undergo endoscopic retrograde cholangiopancreatography (ERCP) in the
USA alone. The reason for this is that duodenoscopes contain tiny moving parts, used to aim transendoscopic
tools sideways at the endoscope tip, which harbor bacteria. In response to the alarming infection rates, in August
2019 the FDA issued a call-to-action for medical device manufactures to develop novel, disposable devices for
ERCP, and for hospitals to rapidly adopt them once available.
Our Innovation is to enable ERCP by augmenting a standard endoscope with a novel low-cost disposable
steerable sheath/endcap system. Our innovative steerable sheath (which passes through the endoscope port)
uses stiffness asymmetry in two thin-walled tubes to enable steering of trans-endoscopic instruments carried in
its large central lumen. The tubes are attached at their tips, enabling the stiffness asymmetry to transform small
axial tube motions into dexterous local bending at the endoscope tip. The result is an inexpensive, disposable
device for dexterously steering the flexible guidewires, cannulas, and sphincterotomes used in ERCP. At the
endoscope tip, the sheath passes through a curved channel built into a custom endcap that (1) aims it sideways
and (2) provides side-view-visualization via an integrated mirror.
Our approach in Aim 1 is to design a clinically-ready version of our steerable sheath/cap system by optimizing
tube mechanical properties while designing for scalable manufacturing. Aim 2 focuses on designing the end
cap for optimal tool delivery and side-view mirror-based visualization. Aim 3 focuses on statistically powered
experiments to compare our new device to standard duodenoscopes in terms of papilla cannulation rate, can-
nulation time, and navigation time to the duodenum, and an animal pilot study to demonstrate in vivo usability.
Success in these aims will strongly motivate the Phase III activities described in the Commercialization Strategy
document (supported by private capital after the conclusion of this Phase II SBIR) where we complete the FDA
510(k) clearance process, and release our device to the commercial market.Narrative: Public Health Relevance
Complex, difficult-to-sterilize duodenoscopes have recently been identified as the source of approximately
40,000 infections per year in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP),
resulting in a call-to-action by the FDA to create new tools that prevent infections. EndoTheia is answering this
call by creating a new low-cost, disposable, steerable device that enables safer ERCP interventions. Success in
this research will solve the public health challenge of duodenoscope cross-contamination, sparing many patients
from life-threatening infections.

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

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