Clinical trial NCT04628949: A Single-Use Duodenoscope in a Real-World Setting
Official title: A Single-Use Duodenoscope in a Real-World Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Keywords: Endoscopic Retrograde Cholangiopancreatography
ERCP
Duodenoscope
Endoscope
aScope Duodeno
aBox
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
Collaborators: name: Ambu Inc.
name: Infinite Clinical Solutions
name: Prelude Dynamics
First posted: 2020-11-16
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Non-Randomized, Single-Arm, Post-Market Observational Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).
timeFrame: Procedure Completion (Day 0)
Secondary outcomes:
measure: To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.
timeFrame: Procedure Completion (Day 0)
measure: To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure.
timeFrame: Procedure Completion (Day 0)
measure: To evaluate rate of successful completion of a converted ERCP procedure.
timeFrame: Procedure Completion (Day 0)
measure: To evaluate the device deficiency rate for the aScope™ Duodeno endoscope.
timeFrame: Procedure Completion (Day 0)
measure: To evaluate physician satisfaction with the aScope™ Duodeno endoscope.
timeFrame: Procedure Completion (Day 0)
Other outcomes:
measure: To evaluate safety of the aScope™ Duodeno endoscope in ERCP.
timeFrame: Day 30 (+3) Post-Procedure
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University, University Hospital
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Oceanside
country: United States
facility: Mount Sinai South Nassau
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Ambu Inc.
name: Elizabeth Smith
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Baron, Kozarek, Carr-Locke, et al. ERCP 3rd Edition. Elsevier. 2019.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.