P1704 - Preliminary Clinical Evaluation of a Novel Single Use Duodenoscope: A Single Center Experience

Prashant Bhenswala, MD¹, Iman Andalib, MD², Frank Gress, MD^2
1South Nassau Communities Hospital, Oceanside, NY; ²Icahn School of Medicine at Mount Sinai, Oceanside, NY

Introduction: The standard reusable duodenoscope is heavily reliant on the high level disinfection cleaning process to ensure patient safety, avoid infectious outbreaks and prevent cross-contamination risk between patients. This risk is essentially eliminated with the use of single-use disposable duodenoscopes. The aim of this study was to evaluate and rate the feasibility, safety, performance, and user experience of a new novel single use duodenoscope (aScope Duodeno, Ambu Medical, Columbia, MD, USA) in the clinical setting.

Methods: We conducted an IRB approved single center prospective case series of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures performed using a novel single use duodenoscope. A total of 25 subjects were enrolled into the study between August 2020 and March 2021. Indications for ERCP included both biliary and/or pancreatic indications. ERCP cases were graded on level of complexity and limited to Grades 1-3 procedures as per American Society of Gastrointestinal Endoscopy (ASGE) ERCP Complexity Scoring System. Two expert advanced endoscopists who had performed over 1500 ERCP procedures each prior to the study performed the procedures with the new single use duodenoscope. The outcomes measured included individual performance ratings using a Scale 1 (Poor) -5 (Best)) for the device (optics, maneuverability, suction/air controls, elevator control), completion of ERCP with device, and short and long term adverse events/complications (based on immediate, 24 hours, 7 days, and 30 days follow-up).

Results: The procedural complexity for the ERCP cases performed were: Grade 1: 10 cases (40 %), Grade 2: 12 cases (48 %), and Grade 3: 3 cases (12 %). Twenty-one (84 %) of ERCP cases were completed using the single use duodenoscope while 4 (16 %) required both the single-use duodenoscope followed by conversion to a reusable duodenoscope due to inability to position the instrument to accomplish the necessary clinical objective. Median overall satisfaction was 3.9 out of 5 (range 1-5). One adverse event was reported: mild post-ERCP pancreatitis requiring 2 day admission.

Discussion: Experienced advanced endoscopists completed a range of low-mid complex ERCP cases using this novel single use duodenoscope in the majority of cases. Further enhancements to this device are ongoing to improve ease of use, maneuverability and clinical effectiveness.


Disclosures:


Prashant Bhenswala, MD¹, Iman Andalib, MD², Frank Gress, MD². P1704 - Preliminary Clinical Evaluation of a Novel Single Use Duodenoscope: A Single Center Experience, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.