NCT06581016

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Gastrointestinal Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2024-08-30
• Last updated: 2026-01-09

Locations

1 site across 1 country: Denmark