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

January 7, 2026 updated by: Camilla Kjelkvist-Born, Zealand University Hospital

Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Recruiting
        • Zealand University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Camilla Kjelkvist-Born, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-use gastroscope
In the first period all gastroscopies in the operating theater will be performed with single-use gastroscopes.
Device: Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Device: Ambu aScope Gastro Large
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Active Comparator: Reusable gastroscope
In the second period all gastroscopies in the operation theater will be performed with reusable gastroscopes.
Device: Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Device: Therapeutic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of single-use gastroscopes vs reusable gastroscopes
Time Frame: 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.
From admission to discharge, up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

University Hospital, Umeå

Investigators

  • Study Chair: Lasse Bremholm Hansen, PhD,ass.prof, Surgical department of Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUSUES_COP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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