Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2021-01-25
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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aScope™ Duodeno endoscope and aBox™ Duodeno
Eligible subjects who are undergoing non-emergent, clinically indicated ERCP using aScope™ Duodeno endoscope and aBox™ Duodeno.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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. 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.
18 Years
ALL
No
Sponsors
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Ambu Inc.
INDUSTRY
Infinite Clinical Solutions
UNKNOWN
Prelude Dynamics
UNKNOWN
Ambu A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Smith
Role: STUDY_DIRECTOR
Ambu Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Colorado Hospital
Aurora, Colorado, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Indiana University, University Hospital
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Mount Sinai South Nassau
Oceanside, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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CIS-018
Identifier Type: -
Identifier Source: org_study_id
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