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

27. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Surveillance gastroscopy for Barrett's esophagus

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Ambu aScope Gastro
CE-merkede engangsgastroskop fra Ambu brukes i engangsgruppen.
Aktiv komparator: 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.
Enhet: Reusable diagnostic gastroscopes (Olympus)
Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endoscopist-rated composite usability score
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Technical success of single-use gastroscopes vs reusable gastroscopes
Tidsramme: 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
Tidsramme: During the procedure
Frequency of gastroscopies requiring cross-over to another gastroscope
During the procedure
Frequency of predefined endoscopic findings
Tidsramme: 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
Tidsramme: 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
Tidsramme: 30 days after the procedure
Mortality within 30 days after the procedure
30 days after the procedure
Duration of procedure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zealand University Hospital

Etterforskere

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

Publikasjoner og nyttige lenker

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

27. juli 2026

Primær fullføring (Antatt)

30. oktober 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. juli 2026

Først lagt ut (Faktiske)

27. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SUSUES_endoscopyunit

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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