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Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit

NCT07727226 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-07-28

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity.

The main question the study aims to answer is:

\- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit?

Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings.

Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable gastroscope.

Conditions

  • Upper Gastrointestinal Disorder

Interventions

DEVICE

Ambu aScope Gastro

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

DEVICE

Reusable diagnostic gastroscopes (Olympus)

Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Lasse Bremholm Hansen, PhD,ass.prof · Surgical department of Zealand University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2027-10-30
Completion
2027-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727226 on ClinicalTrials.gov