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Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR
Sponsor: Zealand University Hospital
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.
Official title: Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2024-09-01
Completion Date
2026-09-30
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Ambu aScope Gastro Large
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Therapeutic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Locations (1)
Zealand University Hospital
Køge, Denmark