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

NCT06581016 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-01-09

No results posted yet for this 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.

Conditions

  • Upper Gastrointestinal Disorder

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.

Sponsors & Collaborators

  • University Hospital, Umeå

    collaborator OTHER

  • 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
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-08-31
Completion
2026-09-30

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 NCT06581016 on ClinicalTrials.gov