A novel single-use duodenoscope completed more than 80 percent of endoscopic retrograde cholangiopancreatography (ERCP) procedures during a single-center prospective case series.
Only four procedures required switching to a reusable duodenoscope.
The study — an evaluation and rating of the feasibility, safety, performance, and user experience of the Ambu aScope Duodeno — was published as an abstract in The American Journal of Gastroenterology and presented as a poster at the ACG Annual Scientific Meeting last month in Las Vegas.
The median overall satisfaction rating of the single-use scope was 3.9 out of 5. Only one adverse event was reported — mild post-ERCP pancreatitis.
The ERCP procedures were graded on a 1-3 complexity scale. Forty percent of the procedures done in the study were Grade 1, 48 percent were Grade 2, and the remaining 12 percent were Grade 3 (the most complex).
Reusable duodenoscopes rely heavily on high-level disinfection to ensure patient safety by preventing cross-contamination and avoiding infection, the authors write in the introduction. This risk, they add, “is essentially eliminated” with single-use duodenoscopes.
The study, done at Mount Sinai Health System between August, 2020, and March, 2021, included 25 subjects. The procedures were done by advanced endoscopists who have performed 1,500 ERCPs apiece.
“Further enhancements to this device are ongoing to improve ease of use, maneuverability and clinical effectiveness,” the authors write in the conclusion.