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RECRUITING
NCT06581016
NA

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

Sponsor: Zealand University Hospital

View on ClinicalTrials.gov

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

Interventions

DEVICE

Ambu aScope Gastro

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

DEVICE

Ambu aScope Gastro Large

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

DEVICE

Diagnostic gastroscopes, Olympus

Reusable gastroscopes from Olympus are used in the reusable group.

DEVICE

Therapeutic gastroscopes, Olympus

Reusable gastroscopes from Olympus are used in the reusable group.

Locations (1)

Zealand University Hospital

Køge, Denmark