Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR
NCT ID: NCT06581016
Last Updated: 2026-01-09
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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RECRUITING
NA
700 participants
INTERVENTIONAL
2024-09-01
2026-09-30
Brief Summary
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\- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies?
Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups.
Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-use gastroscope
In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Ambu aScope Gastro Large
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable gastroscope
In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Therapeutic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Interventions
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Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Ambu aScope Gastro Large
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Therapeutic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Umeå
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Camilla Kjelkvist-Born
Principal Investigator
Principal Investigators
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Lasse Bremholm Hansen, PhD,ass.prof
Role: STUDY_CHAIR
Surgical department of Zealand University Hospital
Locations
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Zealand University Hospital
Køge, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9.
Turk DJ, Kozarek RA, Botoman VA, Patterson DJ, Ball TJ. Disposable endoscopic biopsy forceps: comparison with standard forceps of sample size and adequacy of specimen. J Clin Gastroenterol. 1991 Feb;13(1):76-8.
Forbes N, Elmunzer BJ, Allain T, Parkins MD, Sheth PM, Waddell BJ, Du K, Douchant K, Oladipo O, Saleem A, Cartwright S, Chau M, Howarth M, McKay J, Nashad T, Ruan Y, Bishay K, Gonzalez-Moreno E, Meng ZW, Bass S, Bechara R, Cole MJ, Jalink DW, Mohamed R, Turbide C, Belletrutti PJ, Kayal A, Kumar PR, Hilsden RJ, Buret AG, Hookey L, Heitman SJ. Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):191-200. doi: 10.1001/jamainternmed.2022.6394.
Ross AS, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Moore D, Panduro K, Peetermans JA, Insull J, Rousseau MJ, Tirrell GP, Muthusamy VR. Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison. Gastrointest Endosc. 2020 Feb;91(2):396-403. doi: 10.1016/j.gie.2019.08.032. Epub 2019 Nov 1.
Bruno MJ, Beyna T, Carr-Locke D, Chahal P, Costamagna G, Devereaux B, Giovannini M, Goenka MK, Khor C, Lau J, May G, Muthusamy VR, Patel S, Petersen BT, Pleskow DK, Raijman I, Reddy DN, Repici A, Ross AS, Sejpal DV, Sherman S, Siddiqui UD, Ziady C, Peetermans JA, Rousseau MJ, Slivka A; EXALT Single-use Duodenoscope Study Group. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023 Dec;55(12):1103-1114. doi: 10.1055/a-2131-7180. Epub 2023 Jul 18.
Ramai D, Smit E, Kani HT, Papaefthymiou A, Warner L, Chandan S, Dhindsa B, Facciorusso A, Gkolfakis P, Ofosu A, Barakat M, Adler DG. Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis. Dig Liver Dis. 2024 Jan;56(1):123-129. doi: 10.1016/j.dld.2023.02.022. Epub 2023 Mar 30.
Luo X, Ji M, Zhang S, Chen X, Zong Y, Zhang X, Hu H, Hao X, Shao L, Sun C, Shi H, Wang J, Wang B, Li P. Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial. Gastrointest Endosc. 2022 Aug;96(2):250-261. doi: 10.1016/j.gie.2022.03.024. Epub 2022 Apr 4.
Li DF, Shi RY, Tian YH, Xu ZL, Zhou YS, Sun XJ, Cai JW, Fang YY, Peng H, Wang JM, Dong T, Cai YD, Yao J, Wang LS. The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial. Z Gastroenterol. 2022 Sep;60(9):1314-1319. doi: 10.1055/a-1555-0568. Epub 2021 Nov 12.
van der Ploeg K, de Jonge PJF, Lammers WJ, Koch AD, Vos MC, Paulsen V, Aabakken L, Bruno M. Performance of a single-use gastroscope for esophagogastroduodenoscopy: Prospective evaluation. Endosc Int Open. 2024 Mar 18;12(3):E428-E434. doi: 10.1055/a-2271-2303. eCollection 2024 Mar.
Ebigbo A, Tadic V, Schlottmann J, Braun G, Prinz F, Wanzl J, Ayoub M, Kraus L, Scheppach M, Nagl S, Schnoy E, Weber T, Probst A, Messmann H, Rommele C. Evaluation of a single-use gastroscope in patients presenting with suspected upper gastrointestinal hemorrhage: a pilot feasibility study (One-Scope I). Endoscopy. 2023 Oct;55(10):940-944. doi: 10.1055/a-2089-5969. Epub 2023 May 9.
Han ZL, Lin BT, Wang ZJ, Chen X, Xi YY, Wang JF, Qiao WG, Huang Y, Lin ZZ, Huang SH, Chua TY, Liu SD, Luo XB. Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos). Dig Endosc. 2023 Nov;35(7):857-865. doi: 10.1111/den.14548. Epub 2023 Apr 5.
Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30.
Larsen S, Kalloo A, Hutfless S. The hidden cost of colonoscopy including cost of reprocessing and infection rate: the implications for disposable colonoscopes. Gut. 2020 Feb;69(2):197-200. doi: 10.1136/gutjnl-2019-319108. Epub 2019 Aug 14. No abstract available.
Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available.
Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar.
Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17.
Namburar S, von Renteln D, Damianos J, Bradish L, Barrett J, Aguilera-Fish A, Cushman-Roisin B, Pohl H. Estimating the environmental impact of disposable endoscopic equipment and endoscopes. Gut. 2022 Jul;71(7):1326-1331. doi: 10.1136/gutjnl-2021-324729. Epub 2021 Dec 1.
Rodriguez de Santiago E, Dinis-Ribeiro M, Pohl H, Agrawal D, Arvanitakis M, Baddeley R, Bak E, Bhandari P, Bretthauer M, Burga P, Donnelly L, Eickhoff A, Hayee B, Kaminski MF, Karlovic K, Lorenzo-Zuniga V, Pellise M, Pioche M, Siau K, Siersema PD, Stableforth W, Tham TC, Triantafyllou K, Tringali A, Veitch A, Voiosu AM, Webster GJ, Vienne A, Beilenhoff U, Bisschops R, Hassan C, Gralnek IM, Messmann H. Reducing the environmental footprint of gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement. Endoscopy. 2022 Aug;54(8):797-826. doi: 10.1055/a-1859-3726. Epub 2022 Jul 8.
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Related Links
Access external resources that provide additional context or updates about the study.
US Food and Drug Administration. News \& Events; FDA Newsroom; Press Announcements. FDA Continues Efforts to Support Innovation in Medical Device Sterilization (August 3, 2022). Accessed: 21 July 2023.
Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. \[Accessed Fri Jul 05 2024\].
Other Identifiers
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SUSUES_COP
Identifier Type: -
Identifier Source: org_study_id
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