NCT04628949

A Single-Use Duodenoscope in a Real-World Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Ambu A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

Detailed description

This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.

Conditions

• Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

Type	Name	Description
DEVICE	aScope™ Duodeno endoscope and aBox™ Duodeno	The aScope™ Duodeno endoscope is a sterile single-use disposable duodenoscope indicated for endoscopic retrograde cholangiopancreatography (ERCP) procedures.The aScope™ Duodeno endoscope is designed to be used with aBox Duodeno, endoscopic accessories and other ancillary equipment for ERCP procedures. The aBox Duodeno is the console that is necessary for processing the endoscope camera´s video image, regarding the remote switches and output video and recorder data. The aBox Duodeno is designed to be used with the aScope™ Duodeno endoscope.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-01-27
• Completion: 2022-02-28
• First posted: 2020-11-16
• Last updated: 2022-08-01

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study