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Upper Gastrointestinal DisorderNCT07033286

Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy. 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 and Diagnostic gastroscopes, Olympus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteDenmark
Study dates
5 Jun 2023to 13 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patients of any gender, 18 years of age or older
  • Diagnostic EGD without general anaesthesia

Who cannot join

  • ASA-score of 4 or higher
  • Unstable patient
  • Suspicion of active bleeding
  • Anticoagulants not withheld due to regional guidelines

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Zealand University Hospital

    Køge, 4600

Other trials in Denmark

About this study

Official title: Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope - A Prospective Non-randomized Controlled Single Centre Study

We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy.

Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.

Being tested
Ambu aScope Gastro, Diagnostic gastroscopes, Olympus
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Esophagogastroduodenoscope, Single-use, Reusable, Bedside
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.

  • Diagnostic gastroscopes, OlympusDevice

    Reusable gastroscopes from Olympus are used in the reusable group.

Study groups in NCT07033286
Study groupRoleWhat they receive
Reusable gastroscope in the endoscopy unitActive comparatorIn the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.
Receives: Device: Diagnostic gastroscopes, Olympus
Single-use gastroscope bedside in the patient's roomExperimentalIn the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.
Receives: Device: Ambu aScope Gastro

What is being measured

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

  1. Time from the indication/decision for early endoscopy to procedure

    Measured: From indication to procedure, up to two weeks

  2. Endoscopists' rating of the gastroscope

    The endoscopists' rating of the gastroscope

    Measured: Immediately after procedure

Secondary outcomes (8)

  1. Time from admission to procedure

    Measured: From admission to procedure, up to 3 months

  2. Time from procedure to discharge

    Measured: From procedure to discharge, up to 3 months

  3. Duration of the procedure

    Measured: During the procedure

  4. Did the patient need sedation or local anaesthetic throat spray?

    Frequency of use of sedation and/or local anaesthetic throat spray in each group.

    Measured: During the procedure

  5. Technical success

    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

  6. Complications to gastroscopy

    Measured: 24 and 72 hour follow-up after procedure

  7. Need for converting to general anaesthesia or reusable gastroscope

    Did the patient need a new gastroscopy during admission? If so, what is the reason for that, according to the patient's medical record?

    Measured: During admission, up to 3 months

  8. Findings during the procedure

    The frequency of various findings observed during the procedure in each group (e.g., gastric ulcer, varices, stenosis), based on the procedure documentation in the patients' medical records.

    Measured: During the procedure

Timeline

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

  1. First posted24 Jun 2025
  2. Study start5 Jun 2023
  3. Primary completion13 Jun 2024
  4. Study completion13 Jul 2024

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
Prospective, quality assurance study. Non-randomized, controlled single center feasibility study. Comparing a period where subacute gastroscopies are performed in the endoscopy unit (reusable gastroscopes) with a period where they are performed bedside in the patients room (single-use gastroscopes).
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07033286
Sponsor's protocol ID
BedsideGAS_pilot
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26.

    PubMed 34186052

  • Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.

    PubMed 31706060

  • Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282.

    PubMed 35048654

  • Gralnek IM, Camus Duboc M, Garcia-Pagan JC, Fuccio L, Karstensen JG, Hucl T, Jovanovic I, Awadie H, Hernandez-Gea V, Tantau M, Ebigbo A, Ibrahim M, Vlachogiannakos J, Burgmans MC, Rosasco R, Triantafyllou K. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Nov;54(11):1094-1120. doi: 10.1055/a-1939-4887. Epub 2022 Sep 29.

    PubMed 36174643

  • Jeong N, Kim KS, Jung YS, Kim T, Shin SM. Delayed endoscopy is associated with increased mortality in upper gastrointestinal hemorrhage. Am J Emerg Med. 2019 Feb;37(2):277-280. doi: 10.1016/j.ajem.2018.05.049. Epub 2018 May 24.

    PubMed 29848459

  • Siau K, Hodson J, Ingram R, Baxter A, Widlak MM, Sharratt C, Baker GM, Troth T, Hicken B, Tahir F, Magrabi M, Yousaf N, Grant C, Poon D, Khalil H, Lee HL, White JR, Tan H, Samani S, Hooper P, Ahmed S, Amin M, Mahgoub S, Asghar K, Leet F, Harborne MJ, Polewiczowska B, Khan S, Anjum MR, McFarlane M, Mozdiak E, O'Flynn LD, Blee IC, Molyneux RM, Kurian A, Abbas SN, Abbasi A, Karim A, Yasin A, Khattak F, White J, Ahmed R, Morgan JA, Alleyne L, Alam MA, Palaniyappan N, Rodger VJ, Sawhney P, Aslam N, Okeke T, Lawson A, Cheung D, Reid JP, Awasthi A, Anderson MR, Timothy JR, Pattni S, Ahmad S, Townson G, Shearman J, Giljaca V, Brookes MJ, Disney BR, Guha N, Thomas T, Norman A, Wurm P, Shah A, Fisher NC, Ishaq S, Major G. Time to endoscopy for acute upper gastrointestinal bleeding: Results from a prospective multicentre trainee-led audit. United European Gastroenterol J. 2019 Mar;7(2):199-209. doi: 10.1177/2050640618811491. Epub 2018 Oct 28.

    PubMed 31080604

  • Garg SK, Anugwom C, Campbell J, Wadhwa V, Gupta N, Lopez R, Shergill S, Sanaka MR. Early esophagogastroduodenoscopy is associated with better Outcomes in upper gastrointestinal bleeding: a nationwide study. Endosc Int Open. 2017 May;5(5):E376-E386. doi: 10.1055/s-0042-121665.

    PubMed 28512647

  • Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.

    PubMed 33567467

Questions about this trial

What is this clinical trial studying?

A study testing Ambu aScope Gastro 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 4 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: finished, as of the sponsor's last update on 27 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from the indication/decision for early endoscopy to procedure (time frame: From indication to procedure, up to two weeks). The study lists 2 primary outcomes in all. 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 NCT07033286, which also lists 8 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 27 Jun 2025.

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