NCT06771102

Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy. Participants in the first period will be scheduled for gastroscopy with a re-usable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the ward (bed-side) with a single-use 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	Diagnostic gastroscopes, Olympus	Reusable gastroscopes from Olympus are used in the reusable group.

Timeline

• Start date: 2025-01-13
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-01-13
• Last updated: 2025-06-15

Locations

1 site across 1 country: Denmark