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Upper Gastrointestinal DisorderNCT06581016

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

A study testing Ambu aScope Gastro, Ambu aScope Gastro Large and Diagnostic gastroscopes, Olympus in people with Upper Gastrointestinal Disorder, run by Zealand University Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Gastrointestinal Disorder
What is being tested?
Ambu aScope Gastro, Ambu aScope Gastro Large and Diagnostic gastroscopes, Olympus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteDenmark
Study dates
1 Sep 2024to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Camilla Kjelkvist-Born, MD contact

+4528263875

camkj@regionsjaelland.dk

Marie Louise Malmstrøm, MD, PhD contact

malmstroem@gmail.com

Denmark1 site, 1 recruiting

  • Zealand University Hospital

    Køge, 4600

    Camilla Kjelkvist-Born, MD, +4528263875, camkj@regionsjaelland.dk

    Marie Louise Malmstrøm, MD, PhD, malmstroem@gmail.com

    Recruiting

Other trials in Denmark

About this study

Official title: Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients

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?
Read more

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.

Being tested
Ambu aScope Gastro, Ambu aScope Gastro Large, Diagnostic gastroscopes, Olympus, Therapeutic gastroscopes, Olympus
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambu aScope GastroDevice

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

  • Ambu aScope Gastro LargeDevice

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

  • Diagnostic gastroscopes, OlympusDevice

    Reusable gastroscopes from Olympus are used in the reusable group.

  • Therapeutic gastroscopes, OlympusDevice

    Reusable gastroscopes from Olympus are used in the reusable group.

Study groups in NCT06581016
Study groupRoleWhat they receive
Single-use gastroscopeExperimentalIn the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
Receives: Device: Ambu aScope Gastro; Device: Ambu aScope Gastro Large
Reusable gastroscopeActive comparatorIn the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
Receives: Device: Diagnostic gastroscopes, Olympus; Device: Therapeutic gastroscopes, Olympus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From admission to discharge, up to 3 months

Secondary outcomes (9)

  1. Complications

    Complications to gastroscopy

    Measured: 24 hours and 72 hours follow-up after procedure

  2. 30th day mortality

    Mortality after 30 days after procedure

    Measured: 30 days

  3. Endoscopist's rating of gastroscope

    The endoscopist's rating of the gastroscope

    Measured: Right after procedure

  4. Duration of procedure

    The time from intubation of gastroscope until gastroscope removed from esophagus.

    Measured: During the procedure

  5. Time from procedure to discharge

    Time from procedure to discharge

    Measured: From procedure to discharge, up to 3 months

  6. Success of specific therapeutic procedures

    E.g. success in treating ulcers, banding or stenting

    Measured: During the procedure

  7. Need of new gastroscopy

    Need of new gastroscopy during admission

    Measured: During admission, up to 3 months

  8. Readmission

    Does the patient need readmission after discharge

    Measured: 30 days after procedure

  9. Sufficient ability to target the biopsy if taken

    Successful biopsy which the pathologist can use to either diagnose the patient or to reject a diagnose.

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2024
  2. Study start1 Sep 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-inferiority, quality assurance study comparing a period where single-use gastroscopes are used with a period where reusable gastroscopes are used.
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06581016
Sponsor's protocol ID
SUSUES_COP
Status last verified
Jan 2026
First submitted
26 Aug 2024
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2007750

  • 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.

    PubMed 36689215

  • 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.

    PubMed 31679738

  • 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.

    PubMed 37463599

  • 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.

    PubMed 37003844

  • 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.

    PubMed 35381230

  • 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.

    PubMed 34768288

  • 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.

    PubMed 38504741

  • 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.

    PubMed 37160261

  • 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.

    PubMed 36905288

  • 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.

    PubMed 32891225

  • 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.

    PubMed 35262904

  • 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.

    PubMed 31413166

  • 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.

    PubMed 30772837

  • 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.

    PubMed 38504744

Questions about this trial

What is this clinical trial studying?

A study testing Ambu aScope Gastro, Ambu aScope Gastro Large and Diagnostic gastroscopes, Olympus in people with Upper Gastrointestinal Disorder, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Camilla Kjelkvist-Born, MD (+4528263875, camkj@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success of single-use gastroscopes vs reusable gastroscopes (time frame: From admission to discharge, up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06581016, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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