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A Single-Use Duodenoscope in a Real-World Setting

NCT04628949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2022-08-01

No results posted yet for this study

Summary

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

Conditions

  • Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

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.

Sponsors & Collaborators

  • Ambu Inc.

    collaborator INDUSTRY

  • Infinite Clinical Solutions

    collaborator UNKNOWN

  • Prelude Dynamics

    collaborator UNKNOWN

  • Ambu A/S

    lead INDUSTRY

Principal Investigators

  • Elizabeth Smith · Ambu Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2022-01-27
Completion
2022-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04628949 on ClinicalTrials.gov