A Single-Use Duodenoscope in a Real-World Setting

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

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP)
• Intervention / Treatment: Device: aScope™ Duodeno endoscope and aBox™ Duodeno

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 Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60523
      • Southwest Gastroenterology
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University, University Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Oceanside, New York, United States, 11572
      • Mount Sinai South Nassau
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety of the aScope™ Duodeno endoscope in ERCP.	Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.	Day 30 (+3) Post-Procedure

Collaborators and Investigators

• Sponsor: Ambu A/S
• Collaborators: Ambu Inc.; Infinite Clinical Solutions; Prelude Dynamics
• Investigators: Study Director: Elizabeth Smith, Ambu Inc.

Publications and helpful links

General Publications

• Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
• Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. United European Gastroenterol J. 2018 Dec;6(10):1448-1460. doi: 10.1177/2050640618808157. Epub 2018 Oct 19.
• Baron, Kozarek, Carr-Locke, et al. ERCP 3rd Edition. Elsevier. 2019.
• Lee DH, Kim DB, Kim HY, Baek HS, Kwon SY, Lee MH, Park JC. Increasing potential risks of contamination from repetitive use of endoscope. Am J Infect Control. 2015 May 1;43(5):e13-7. doi: 10.1016/j.ajic.2015.01.017. Epub 2015 Feb 25.
• Alfa MJ, Olson N, DeGagne P, Jackson M. A survey of reprocessing methods, residual viable bioburden, and soil levels in patient-ready endoscopic retrograde choliangiopancreatography duodenoscopes used in Canadian centers. Infect Control Hosp Epidemiol. 2002 Apr;23(4):198-206. doi: 10.1086/502035.
• Petersen BT. Duodenoscope reprocessing: risk and options coming into view. Gastrointest Endosc. 2015 Sep;82(3):484-7. doi: 10.1016/j.gie.2015.07.004. No abstract available.
• Ross AS, Baliga C, Verma P, Duchin J, Gluck M. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc. 2015 Sep;82(3):477-83. doi: 10.1016/j.gie.2015.04.036. Epub 2015 Jun 16.
• USA FDA: Medical Device Safety: Safety Communications. The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication. 12 April 2019.
• USA FDA: Medical Device Safety: Safety Communications. The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication. 29 August 2019.
• Balan GG, Rosca I, Ursu EL, Fifere A, Varganici CD, Doroftei F, Turin-Moleavin IA, Sandru V, Constantinescu G, Timofte D, Stefanescu G, Trifan A, Sfarti CV. Duodenoscope-Associated Infections beyond the Elevator Channel: Alternative Causes for Difficult Reprocessing. Molecules. 2019 Jun 25;24(12):2343. doi: 10.3390/molecules24122343.
• Cotton PB, Eisen G, Romagnuolo J, Vargo J, Baron T, Tarnasky P, Schutz S, Jacobson B, Bott C, Petersen B. Grading the complexity of endoscopic procedures: results of an ASGE working party. Gastrointest Endosc. 2011 May;73(5):868-74. doi: 10.1016/j.gie.2010.12.036. Epub 2011 Mar 5.
• ASGE Standards of Practice Committee, Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ERCP; Endoscopic Retrograde Cholangiopancreatography; Duodenoscope; Endoscope; aScope Duodeno; aBox
• Other Study ID Numbers: CIS-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No