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

Zealand University Hospital

Status: Enrolling

Conditions: Upper Gastrointestinal Disorder

Treatments: Device: Ambu aScope Gastro; Device: Diagnostic gastroscopes, Olympus

Study type: Interventional

Funder types: Other

Identifiers

NCT06771102

SUSUES_bedsideGAS

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Reusable gastroscope in the endoscopy unit

Active Comparator group

Description:

In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.

Treatment:

Device: Diagnostic gastroscopes, Olympus

Single-use gastroscope bedside in the patient's room

Experimental group

Description:

In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.

Treatment:

Device: Ambu aScope Gastro