Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study

Area of Science:

• Gastroenterology
• Medical Devices
• Infectious Disease Control

Background:

• Reusable duodenoscopes pose infectious risks.
• Single-use disposable duodenoscopes (SDDs) were developed to mitigate these risks.
• Two SDDs are currently available in the United States.

Purpose of the Study:

• To compare the safety and efficacy of the two available SDDs in the United States.
• Evaluate performance, procedure details, and adverse events associated with each SDD.

Main Methods:

• A comparative study involving 2 SDDs in consecutive ERCP procedures.
• Expert endoscopists from 9 academic centers performed the procedures.
• Data collected included performance ratings, procedure details, and adverse events.

Main Results:

• 201 patients were included; 129 with Exalt and 72 with aScope Duodeno.
• Technical success was 92% for both devices.
• No adverse events were related to the SDDs; conversion rates to reusable duodenoscopes were 10% for Exalt and 22% for aScope Duodeno.

Conclusions:

• The two single-use disposable duodenoscopes (SDDs) showed comparable safety and efficacy.
• Further enhancements to these devices are anticipated to improve maneuverability and clinical effectiveness.