An interventional study of Ambu aScope Gastro and Reusable diagnostic gastroscopes (Olympus) in Upper Gastrointestinal Disorder, sponsored by Zealand University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
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
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)
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable diagnostic gastroscopes from Olympus are used in the reusable group.
Endoscopist-rated composite usability score
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.
Time frame: Procedure day (immediately after completion of the procedure)
Cost per gastroscopy during the single-use period compared with the reusable period
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.
Time frame: During the gastroscopy procedure and completion of all procedure-related activities (same day).
Technical success of single-use gastroscopes vs reusable gastroscopes
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.
Time frame: During the procedure
Cross-over rate
Frequency of gastroscopies requiring cross-over to another gastroscope
Time frame: During the procedure
Frequency of predefined endoscopic findings
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.
Time frame: During the procedure
Complications
Complications related to gastroscopy
Time frame: 24 hours and 72 hours follow-up after the procedure
30-day mortality
Mortality within 30 days after the procedure
Time frame: 30 days after the procedure
Duration of procedure
The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
Time frame: During the procedure
Technical success rate of therapeutic endoscopic procedures
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.
Time frame: During the procedure
Diagnostic adequacy rate of endoscopic biopsies
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.
Time frame: After completion of the pathology examination (up to 2 months after the procedure)
Plan to share: No
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Zealand University Hospital