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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

ConditionUpper Gastrointestinal Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

ASA-score of 4 or higher

Unstable patient

Suspicion of ventricular retention

Suspicion of active bleeders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ambu aScope Gastro

    Device

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

  • Diagnostic gastroscopes, Olympus

    Device

    Reusable gastroscopes from Olympus are used in the reusable group.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Reusable gastroscope in the endoscopy unitActive comparator 1 intervention
Group B: Single-use gastroscope bedside in the patient's roomExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from the indication/decision for early endoscopy to procedure

Time frame
From indication to procedure, up to two weeks

Secondary outcomes

1

Time from indication to the discharge

Time frame
From indication to discharge, up to 3 months
2

Time from procedure to discharge

Time frame
From procedure to discharge, up to 3 months
3

Duration of the procedure

Time frame
During the procedure
4

Did the patient need sedation or local anesthetic throat spray

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

Source ClinicalTrials.gov
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