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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Technical success of single-use gastroscopes vs reusable gastroscopes — 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.

Trial sites (1)

More Zealand University Hospital trials in Denmark

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