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Endoscope

aScope™ Duodeno endoscope and aBox™ Duodeno for Endoscopic Retrograde Cholangiopancreatography

N/A
Waitlist Available
Research Sponsored by Ambu A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 (+3) post-procedure
Awards & highlights
No Placebo-Only Group

Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 (+3) post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 (+3) post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).
Secondary study objectives
To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.
To evaluate physician satisfaction with the aScope™ Duodeno endoscope.
To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure.
+2 more
Other study objectives
To evaluate safety of the aScope™ Duodeno endoscope in ERCP.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: aScope™ Duodeno endoscope and aBox™ DuodenoExperimental Treatment1 Intervention
Eligible subjects who are undergoing non-emergent, clinically indicated ERCP using aScope™ Duodeno endoscope and aBox™ Duodeno.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aScope™ Duodeno endoscope and aBox™ Duodeno
2021
N/A
~250

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Who is running the clinical trial?

Prelude DynamicsUNKNOWN
Infinite Clinical SolutionsUNKNOWN
Ambu A/SLead Sponsor
23 Previous Clinical Trials
5,491 Total Patients Enrolled
~53 spots leftby Oct 2025