A Single-Use Duodenoscope in a Real-World Setting

Ambu A/S248 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

aScope™ Duodeno endoscope and aBox™ DuodenoDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥ 18 years old. 2. Subject is indicated and scheduled for an elective, non-emergent ERCP. 3. Subject is willing and able to give informed consent and HIPAA authorization. Exclusion Criteria: 1. Subject has altered pancreaticobiliary anatomy including: 1. Billroth II 2. Roux-en-Y gastric bypass 3. Loop gastric bypass 4. Post-Whipple 5. Roux-en-Y hepaticojejunostomy 2. Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae). 3. Subject has any of the following severe co-morbid conditions 1. Morbid obesity (BMI ≥ 40) 2. Unstable cardiopulmonary conditions 3. Severe and uncorrectable coagulopathy 4. Severe and uncorrectable thrombocytopenia 4. Subject has clinically significant esophageal, pyloric or duodenal strictures. 5. Subject has been previously been treated under this investigational plan. 6. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control. 7. Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin. 8. 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.

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Colorado Hospital

Aurora, Colorado, United States

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Indiana University, University Hospital

Outcomes

Primary Outcomes

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.

Time frame: Procedure Completion (Day 0)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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