A Single-Use Duodenoscope in a Real-World Setting

Purpose

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

Condition

  • Endoscopic Retrograde Cholangiopancreatography (ERCP)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Prospective, Non-Randomized, Single-Arm, Post-Market Observational Study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

More Details

Status
Completed
Sponsor
Ambu A/S

Study Contact

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.