Skip to main content
OpenTrials
Completed

NCT Number: NCT07033286

Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Gastrointestinal Disorder Digestive System Diseases Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ambu aScope Gastro

Device

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

Diagnostic gastroscopes, Olympus

Device

Reusable gastroscopes from Olympus are used in the reusable group.

Primary outcomes

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

    Time frame: From indication to procedure, up to two weeks

  2. Endoscopists' rating of the gastroscope

    Time frame: Immediately after procedure

    The endoscopists' rating of the gastroscope

Secondary outcomes

  1. Time from admission to procedure

    Time frame: From admission to procedure, up to 3 months

  2. Time from procedure to discharge

    Time frame: From procedure to discharge, up to 3 months

  3. Duration of the procedure

    Time frame: During the procedure

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

    Time frame: During the procedure

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

  5. Technical success

    Time frame: From admission to discharge, up to 3 months

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

  6. Complications to gastroscopy

    Time frame: 24 and 72 hour follow-up after procedure

  7. Need for converting to general anaesthesia or reusable gastroscope

    Time frame: During admission, up to 3 months

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

  8. Findings during the procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.