A Single-Use Duodenoscope in a Real-World Setting

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP)
• Interventions: Device: aScope™ Duodeno endoscope and aBox™ Duodeno

• Registration Number: NCT04628949
• Lead Sponsor: Ambu A/S

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Study Start: 2021-01-25
• Primary Completion: 2022-01-27
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aScope™ Duodeno endoscope and aBox™ Duodeno	aScope™ Duodeno endoscope and aBox™ Duodeno	Eligible subjects who are undergoing non-emergent, clinically indicated ERCP using aScope™ Duodeno endoscope and aBox™ Duodeno.

Primary Outcome Measures

Name	Time	Method
To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).	Procedure Completion (Day 0)	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the device deficiency rate for the aScope™ Duodeno endoscope.	Procedure Completion (Day 0)	Incidence rate of device deficiencies as defined as either a device failure or device malfunction for the aScope™ Duodeno endoscope during ERCP procedure.
To evaluate physician satisfaction with the aScope™ Duodeno endoscope.	Procedure Completion (Day 0)	Physician reported outcomes questionnaire on physician satisfaction with the aScope™ Duodeno endoscope for ERCP procedures.
To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure.	Procedure Completion (Day 0)	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.
To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.	Procedure Completion (Day 0)	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.
To evaluate rate of successful completion of a converted ERCP procedure.	Procedure Completion (Day 0)	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).

Trial Locations

Locations (9)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mount Sinai South Nassau; 🇺🇸 Oceanside, New York, United States

Southwest Gastroenterology; 🇺🇸 Oak Lawn, Illinois, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Indiana University, University Hospital; 🇺🇸 Indianapolis, Indiana, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States