Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit

July 24, 2026 updated by: Camilla Kjelkvist-Born, Zealand University Hospital

The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity.

The main question the study aims to answer is:

- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit?

Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings.

Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable gastroscope.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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

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:

  • Elective or subacute gastroscopy in the endoscopy unit
  • Age ≥ 18 years

Exclusion Criteria:

  • Surveillance gastroscopy for Barrett's esophagus

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-use gastroscope
During the first study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using single-use gastroscopes.
Device: Ambu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Active Comparator: Reusable gastroscope
During the second study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using reusable gastroscopes.
Device: Reusable diagnostic gastroscopes (Olympus)
Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopist-rated composite usability score
Time Frame: Procedure day (immediately after completion of the procedure)
Comparison of the composite endoscopist-rated performance score of single-use and reusable gastroscopes. The composite score will be calculated as the mean of all items rated on a 5-point Likert-scale questionnaire.
Procedure day (immediately after completion of the procedure)
Cost per gastroscopy during the single-use period compared with the reusable period
Time Frame: During the gastroscopy procedure and completion of all procedure-related activities (same day).

Cost per gastroscopy (EUR) will be calculated for each study period using hospital administrative and procedural data. The calculation will include:

  • Diagnosis-Related Group (DRG) reimbursement value for gastroscopy
  • Purchase cost of the single-use gastroscope
  • Reprocessing cost of reusable gastroscopes
  • Staff time required for preparation and post-procedure work for each gastroscope type
  • Additional hospital costs associated with transferring patients to other hospitals or private providers due to reduced endoscope reprocessing capacity.
During the gastroscopy procedure and completion of all procedure-related activities (same day).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of single-use gastroscopes vs reusable gastroscopes
Time Frame: During the procedure
Technical success will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Technical success is defined as successful advancement of the gastroscope to the second part of the duodenum and the ability to identify or exclude the suspected diagnosis. In procedures with an impassable stenosis or tumor, technical success is defined as successful identification of the lesion and obtaining biopsies sufficient for diagnostic evaluation when clinically indicated. The outcome will be reported as the proportion of procedures meeting the predefined criteria for technical success.
During the procedure
Cross-over rate
Time Frame: During the procedure
Frequency of gastroscopies requiring cross-over to another gastroscope
During the procedure
Frequency of predefined endoscopic findings
Time Frame: During the procedure
Endoscopic findings will be determined by retrospective review of the endoscopy report using predefined study categories. The frequency of each predefined endoscopic finding will be compared between the single-use and reusable gastroscope groups.
During the procedure
Complications
Time Frame: 24 hours and 72 hours follow-up after the procedure
Complications related to gastroscopy
24 hours and 72 hours follow-up after the procedure
30-day mortality
Time Frame: 30 days after the procedure
Mortality within 30 days after the procedure
30 days after the procedure
Duration of procedure
Time Frame: During the procedure
The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
During the procedure
Technical success rate of therapeutic endoscopic procedures
Time Frame: During the procedure
Technical success of therapeutic endoscopic procedures will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Therapeutic procedures include, but are not limited to, endoscopic hemostasis of bleeding ulcers, variceal band ligation, stent placement, foreign body removal, and dilation. Success is defined as successful completion of the intended therapeutic intervention according to the predefined criteria for each procedure (e.g., successful hemostasis, successful band ligation, successful stent deployment, or successful removal of foreign bodies). The outcome will be reported as the proportion of therapeutic procedures meeting the predefined criteria for technical success and compared between the single-use and reusable gastroscope groups.
During the procedure
Diagnostic adequacy rate of endoscopic biopsies
Time Frame: After completion of the pathology examination (up to 2 months after the procedure)
Diagnostic adequacy of endoscopic biopsies will be determined by retrospective review of the pathology report and endoscopy report using predefined study criteria. A biopsy will be considered adequate if the pathological examination provides sufficient information to either establish or exclude the suspected diagnosis. The outcome will be reported as the proportion of biopsies considered diagnostically adequate among procedures where biopsies were obtained and compared between the single-use and reusable gastroscope groups.
After completion of the pathology examination (up to 2 months after 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 (Estimated)

July 27, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUSUES_endoscopyunit

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

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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