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

June 10, 2025 updated by: Camilla Kjelkvist-Born, Zealand University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

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:

  • 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

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
Active Comparator: Reusable gastroscope in the endoscopy unit
In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.
Device: Diagnostic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Experimental: Single-use gastroscope bedside in the patient's room
In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.
Device: Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from the indication/decision for early endoscopy to procedure
Time Frame: From indication to procedure, up to two weeks
From indication to procedure, up to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from indication to the discharge
Time Frame: From indication to discharge, up to 3 months
From indication to discharge, up to 3 months
Duration of the procedure
Time Frame: During the procedure
During the procedure
Did the patient need sedation or local anesthetic throat spray
Time Frame: During the procedure
During the procedure
Technical success
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
Complications to gastroscopy
Time Frame: 24 and 72 hour follow-up after procedure
24 and 72 hour follow-up after procedure
30th day mortality
Time Frame: 30 days
30 days
Endoscopists' rating of the gastroscope
Time Frame: Right after procedure
The endoscopist's rating of the gastroscope
Right after procedure
Time from procedure to discharge
Time Frame: From procedure to discharge, up to 3 months
From procedure to discharge, up to 3 months
Readmission
Time Frame: 30 days after procedure
Does the patient need readmission after discharge?
30 days after procedure
The necessity for a new gastroscopy, including the reasons justifying it
Time Frame: During admission, up to 3 months
Did the patient need a new gastroscopy during admission? If so, what is the reason for that, according to the patient's medical record?
During admission, up to 3 months
Learning curve for nurses at the surgical department
Time Frame: During the second period (one year)
Following each procedure, the nurses will complete a short questionnaire evaluating their level of comfort (from 1-5) during the various steps of the procedure.
During the second period (one year)
Sufficient ability to target the biopsy if taken
Time Frame: During the procedure
Successful biopsy that provides the pathologist with sufficient material to either confirm or rule out a diagnosis. If the biopsy is inadequate, the pathologist will note this in the report.
During the procedure

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

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)

January 13, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUSUES_bedsideGAS

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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