RecruitingNot ApplicableNCT06581016

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

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


Sponsor

Zealand University Hospital

Enrollment

700 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria1

  • None

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Interventions

DEVICEAmbu aScope Gastro

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

DEVICEAmbu aScope Gastro Large

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

DEVICEDiagnostic gastroscopes, Olympus

Reusable gastroscopes from Olympus are used in the reusable group.

DEVICETherapeutic gastroscopes, Olympus

Reusable gastroscopes from Olympus are used in the reusable group.


Locations(1)

Zealand University Hospital

Køge, Denmark

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NCT06581016


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