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NCT Number: NCT06771102

Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy.

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

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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

Location status: Recruiting

Location contact

Camilla Kjelkvist-Born, MD

CONTACT

[email protected]

+4528263875

Camilla Kjelkvist-Born, MD

PRINCIPAL_INVESTIGATOR

Marie Louise Malmstrøm, MD, PhD

CONTACT

[email protected]

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 admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia.

Exclusion criteria

  • ASA-score of 4 or higher
  • Unstable patient
  • Suspicion of ventricular retention
  • Suspicion of active bleeders
  • Need for expert endoscopist to perform the procedure, e.g. stenting
  • Patients < 18 years of age

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

Secondary outcomes

  1. Time from indication to the discharge

    Time frame: From indication to discharge, 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 anesthetic throat spray

    Time frame: During the procedure

  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. Sufficient ability to target the biopsy if taken

    Time frame: During the procedure

    Successful biopsy that provides the pathologist with sufficient material to either confirm or rule out a diagnosis. If the biopsy is inadequate, the pathologist will note this in the report.

  7. Complications to gastroscopy

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

  8. 30th day mortality

    Time frame: 30 days

  9. Readmission

    Time frame: 30 days after procedure

    Does the patient need readmission after discharge?

  10. The necessity for a new gastroscopy, including the reasons justifying it

    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?

  11. Endoscopists' rating of the gastroscope

    Time frame: Right after procedure

    The endoscopist's rating of the gastroscope

  12. Learning curve for nurses at the surgical department

    Time frame: During the second period (one year)

    Following each procedure, the nurses will complete a short questionnaire evaluating their level of comfort (from 1-5) during the various steps of the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Kjelkvist-Born, MD

CONTACT

[email protected]

+4528263875

Marie Louise Malmstrøm, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jul 16, 2026

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.

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