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

Condition(s) studied

Investigational drug(s) / intervention(s)

Ambu aScope Gastro: CE-marked single-use gastroscopes from Ambu are used in the single-use group.

Reusable diagnostic gastroscopes (Olympus): Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Endoscopist-rated composite usability score — 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.
• Cost per gastroscopy during the single-use period compared with the reusable period — 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.

Trial sites (1)

More Zealand University Hospital trials in Denmark

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