A Single-Use Duodenoscope in a Real-World Setting

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

Detailed Description
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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.

Official Title
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A Single-Use Duodenoscope in a Real-World Setting

Conditions
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Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention / Treatment
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* Device: aScope™ Duodeno endoscope and aBox™ Duodeno


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old. Subject is indicated and scheduled for an elective, non-emergent ERCP. Subject is willing and able to give informed consent and HIPAA authorization. Exclusion Criteria: Subject has altered pancreaticobiliary anatomy including: Billroth II Roux-en-Y gastric bypass Loop gastric bypass Post-Whipple Roux-en-Y hepaticojejunostomy Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae). Subject has any of the following severe co-morbid conditions Morbid obesity (BMI ≥ 40) Unstable cardiopulmonary conditions Severe and uncorrectable coagulopathy Severe and uncorrectable thrombocytopenia Subject has clinically significant esophageal, pyloric or duodenal strictures. Subject has been previously been treated under this investigational plan. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control. Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, Non-Randomized, Single-Arm, Post-Market Observational Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aScope™ Duodeno endoscope and aBox™ Duodeno<br>Eligible subjects who are undergoing non-emergent, clinically indicated ERCP using aScope™ Duodeno endoscope and aBox™ Duodeno. | Device: aScope™ Duodeno endoscope and aBox™ Duodeno<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s). | Procedure success will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the ERCP procedure. | Procedure Completion (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures. | Procedure success for sub categories of ERCP procedures will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the stratified sub-categories of ERCP procedures with the the aScope™ Duodeno endoscope. | Procedure Completion (Day 0) | 
| To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure. | Rate of conversion will be measured by the incidence rate of when a conversion to a different endoscope or open procedure is necessitated during the ERCP procedure with the aScope™ Duodeno endoscope. | Procedure Completion (Day 0) | 
| To evaluate rate of successful completion of a converted ERCP procedure. | Successful completion will be measured by the incidence rate of success for converted ERCP procedure as stratified by the conversion method (reusable scope, other endoscope, other procedure). | Procedure Completion (Day 0) | 
| To evaluate the device deficiency rate for the aScope™ Duodeno endoscope. | Incidence rate of device deficiencies as defined as either a device failure or device malfunction for the aScope™ Duodeno endoscope during ERCP procedure. | Procedure Completion (Day 0) | 
| To evaluate physician satisfaction with the aScope™ Duodeno endoscope. | Physician reported outcomes questionnaire on physician satisfaction with the aScope™ Duodeno endoscope for ERCP procedures. | Procedure Completion (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Retrograde Cholangiopancreatography, ERCP, Duodenoscope, Endoscope, aScope Duodeno, aBox