Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR

NCT06581016 | Recruiting

• 1 other identifier: SUSUES_COP
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is: \- 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.

Conditions

Upper Gastrointestinal Disorder

Keywords

Gastroscopy; Upper endoscopy; Gastroscope; Single-use; Reusable

Outcome Measures

Primary Outcomes (1)

• Technical success of single-use gastroscopes vs reusable gastroscopes

  Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines.

  From admission to discharge, up to 3 months

Secondary Outcomes (9)

• Complications

  24 hours and 72 hours follow-up after procedure

• 30th day mortality

  30 days

• Endoscopist's rating of gastroscope

  Right after procedure

• Duration of procedure

  During the procedure

• Time from procedure to discharge

  From procedure to discharge, up to 3 months

Study Arms (2)

Single-use gastroscope

EXPERIMENTAL

In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.

Device: Ambu aScope Gastro; Device: Ambu aScope Gastro Large

Reusable gastroscope

ACTIVE COMPARATOR

In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.

Device: Diagnostic gastroscopes, Olympus; Device: Therapeutic gastroscopes, Olympus

Interventions

Diagnostic gastroscopes, Olympus DEVICE

Reusable gastroscopes from Olympus are used in the reusable group.

Reusable gastroscope

Therapeutic gastroscopes, Olympus DEVICE

Reusable gastroscopes from Olympus are used in the reusable group.

Reusable gastroscope

Ambu aScope Gastro DEVICE

CE-marked single-use gastroscopes from Ambu are used in the single-use group.

Single-use gastroscope

Ambu aScope Gastro Large DEVICE

CE-marked single-use gastroscopes from Ambu are used in the single-use group.

Single-use gastroscope

Eligibility Criteria

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

You may qualify if:

• Acute, subacute or elective gastroscopies in the operating theater
• Age ≥ 18 years

You may not qualify if:

• None

Sponsors & Collaborators

• Zealand University Hospital: lead
• University Hospital, Umeå: collaborator

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Related Publications (19)

• 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.

  PMID: 2007750 BACKGROUND

• 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.

  PMID: 36689215 BACKGROUND

• 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.

  PMID: 31679738 BACKGROUND

• 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.

  PMID: 37463599 BACKGROUND

• 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.

  PMID: 37003844 BACKGROUND

• 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.

  PMID: 35381230 BACKGROUND

• 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.

  PMID: 34768288 BACKGROUND

• 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.

  PMID: 38504741 BACKGROUND

• 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.

  PMID: 37160261 BACKGROUND

• 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.

  PMID: 36905288 BACKGROUND

• 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.

  PMID: 32891225 BACKGROUND

• 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.

  PMID: 35262904 BACKGROUND

• 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.

  PMID: 31413166 BACKGROUND

• 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.

  PMID: 30772837 BACKGROUND

• 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.

  PMID: 38504744 BACKGROUND

• 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.

  PMID: 35718068 BACKGROUND

• 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.

  PMID: 34853058 BACKGROUND

• 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.

  PMID: 35803275 BACKGROUND

• Mackiewicz-Pracka A, Nehring P, Przybylkowski A. Emergency Endoscopic Interventions in Acute Upper Gastrointestinal Bleeding: A Cohort Study. Diagnostics (Basel). 2023 Dec 1;13(23):3584. doi: 10.3390/diagnostics13233584.

  PMID: 38066825 BACKGROUND

Related Links

• 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. \[Accessed Fri Jul 05 2024\].

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Lasse Bremholm Hansen, PhD,ass.prof

  Surgical department of Zealand University Hospital

  STUDY CHAIR

Central Study Contacts

Camilla Kjelkvist-Born, MD

CONTACT

+4528263875; camkj@regionsjaelland.dk

Marie Louise Malmstrøm, MD, PhD

CONTACT

malmstroem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-inferiority, quality assurance study comparing a period where single-use gastroscopes are used with a period where reusable gastroscopes are used.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)