Performance Characteristics and Technical Outcomes of Single-use Vs. Reusable Gastroscopes Evaluated in the or

Not Applicable

Not yet recruiting

• Conditions: Upper Gastrointestinal Disorder
• Interventions: Device: Ambu aScope Gastro; Device: Diagnostic gastroscopes, Olympus; Device: Ambu aScope Gastro Large; Device: Therapeutic gastroscopes, Olympus

• Registration Number: NCT06581016
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study Start: 2024-09-01
• Last Update Posted: 2024-09-03
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-use gastroscope	Ambu aScope Gastro	In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
Single-use gastroscope	Ambu aScope Gastro Large	In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
Reusable gastroscope	Diagnostic gastroscopes, Olympus	In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
Reusable gastroscope	Therapeutic gastroscopes, Olympus	In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.

Primary Outcome Measures

Name	Time	Method
Technical success of single-use gastroscopes vs reusable gastroscopes	From admission to discharge, up to 3 months	Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines.

Secondary Outcome Measures

Name	Time	Method
Complications	24 hours and 72 hours follow-up after procedure	Complications to gastroscopy
30th day mortality	30 days	Mortality after 30 days after procedure
Endoscopist's rating of gastroscope	Right after procedure	The endoscopist's rating of the gastroscope
Duration of procedure	During the procedure	The time from intubation of gastroscope until gastroscope removed from esophagus.
Time from procedure to discharge	From procedure to discharge, up to 3 months	Time from procedure to discharge
Success of specific therapeutic procedures	During the procedure	E.g. success in treating ulcers, banding or stenting
Need of new gastroscopy	During admission, up to 3 months	Need of new gastroscopy during admission
Readmission	30 days after procedure	Does the patient need readmission after discharge
Sufficient ability to target the biopsy if taken	During procedure	Successful biopsy which the pathologist can use to either diagnose the patient or to reject a diagnose.

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark