A Single-Use Duodenoscope in a Real-World Setting

NCT04628949 | Completed FDA Device

• 1 other identifier: CIS-018
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Keywords

Endoscopic Retrograde Cholangiopancreatography; ERCP; Duodenoscope; Endoscope; aScope Duodeno; aBox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.

  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.

  Procedure Completion (Day 0)

• To evaluate rate of successful completion of a converted ERCP procedure.

  Procedure Completion (Day 0)

• To evaluate the device deficiency rate for the aScope™ Duodeno endoscope.

  Procedure Completion (Day 0)

• To evaluate physician satisfaction with the aScope™ Duodeno endoscope.

  Procedure Completion (Day 0)

Other Outcomes (1)

• To evaluate safety of the aScope™ Duodeno endoscope in ERCP.

  Day 30 (+3) Post-Procedure

Study Arms (1)

aScope™ Duodeno endoscope and aBox™ Duodeno

EXPERIMENTAL

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

Device: aScope™ Duodeno endoscope and aBox™ Duodeno

Interventions

aScope™ Duodeno endoscope and aBox™ Duodeno DEVICE

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.

aScope™ Duodeno endoscope and aBox™ Duodeno

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ambu A/S: lead
• Ambu Inc.: collaborator
• Infinite Clinical Solutions: collaborator
• Prelude Dynamics: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60523, United States

Location

Indiana University, University Hospital

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai South Nassau

Oceanside, New York, 11572, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (12)

• 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.

  PMID: 30574315 BACKGROUND

• Baron, Kozarek, Carr-Locke, et al. ERCP 3rd Edition. Elsevier. 2019.

  BACKGROUND

• 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.

  PMID: 25726130 BACKGROUND

• 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.

  PMID: 12002234 BACKGROUND

• 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.

  PMID: 26279349 BACKGROUND

• 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.

  PMID: 26092616 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31242689 BACKGROUND

• 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.

  PMID: 21377673 BACKGROUND

• 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.

  PMID: 31863440 BACKGROUND

• 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.

  PMID: 27546389 BACKGROUND

Study Officials

• Elizabeth Smith

  Ambu Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Non-Randomized, Single-Arm, Post-Market Observational Study

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 16, 2020
• Study Start: January 25, 2021
• Primary Completion: January 27, 2022
• Study Completion: February 28, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)