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

Zealand University Hospital

Status: Enrolling

Conditions: Upper Gastrointestinal Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06581016

SUSUES_COP

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute, subacute or elective gastroscopies in the operating theater
• Age ≥ 18 years

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Single-use gastroscope

Experimental group

Description:

In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.

Treatment:

Device: Ambu aScope Gastro Large

Device: Ambu aScope Gastro

Reusable gastroscope

Active Comparator group

Description:

In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.

Treatment:

Device: Therapeutic gastroscopes, Olympus

Device: Diagnostic gastroscopes, Olympus