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NCT Number: NCT06581016

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

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.

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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

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

Exclusion criteria

  • None

Treatment and study plan

Ambu aScope Gastro

Device

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

Ambu aScope Gastro Large

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.

Therapeutic gastroscopes, Olympus

Device

Reusable gastroscopes from Olympus are used in the reusable group.

Primary outcomes

  1. Technical success of single-use gastroscopes vs reusable gastroscopes

    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.

Secondary outcomes

  1. Complications

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

    Complications to gastroscopy

  2. 30th day mortality

    Time frame: 30 days

    Mortality after 30 days after procedure

  3. Endoscopist's rating of gastroscope

    Time frame: Right after procedure

    The endoscopist's rating of the gastroscope

  4. Duration of procedure

    Time frame: During the procedure

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

  5. Time from procedure to discharge

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

    Time from procedure to discharge

  6. Success of specific therapeutic procedures

    Time frame: During the procedure

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

  7. Need of new gastroscopy

    Time frame: During admission, up to 3 months

    Need of new gastroscopy during admission

  8. Readmission

    Time frame: 30 days after procedure

    Does the patient need readmission after discharge

  9. Sufficient ability to target the biopsy if taken

    Time frame: During procedure

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

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

Collaborators

  • University Hospital, Umeå

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Jan 9, 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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