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

NCT06771102 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-06-15

No results posted yet for this study

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

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.

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
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-01-31
Completion
2027-04-30

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 NCT06771102 on ClinicalTrials.gov