RecruitingNot ApplicableNCT06771102

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


Sponsor

Zealand University Hospital

Enrollment

180 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients of any gender, 18 years of age or older admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia.

Exclusion Criteria6

  • ASA-score of 4 or higher
  • Unstable patient
  • Suspicion of ventricular retention
  • Suspicion of active bleeders
  • Need for expert endoscopist to perform the procedure, e.g. stenting
  • Patients < 18 years of age

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Interventions

DEVICEAmbu aScope Gastro

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

DEVICEDiagnostic gastroscopes, Olympus

Reusable gastroscopes from Olympus are used in the reusable group.


Locations(1)

Zealand University Hospital

Køge, Denmark

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NCT06771102


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