Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit
27 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
300
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Camilla Kjelkvist-Born, MD
- Número de teléfono: +4528263875
- Correo electrónico: camkj@regionsjaelland.dk
Copia de seguridad de contactos de estudio
- Nombre: Marie Louise Malmstrøm, MD, PhD
- Correo electrónico: malmstroem@gmail.com
Ubicaciones de estudio
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Køge, Dinamarca, 4600
- Reclutamiento
- Zealand University Hospital
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Contacto:
- Camilla Kjelkvist-Born, MD
- Número de teléfono: +4528263875
- Correo electrónico: camkj@regionsjaelland.dk
-
Contacto:
- Marie Louise Malmstrøm, MD, PhD
- Correo electrónico: malmstroem@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Elective or subacute gastroscopy in the endoscopy unit
- Age ≥ 18 years
Exclusion Criteria:
- Surveillance gastroscopy for Barrett's esophagus
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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Los gastroscopios de un solo uso con marcado CE de Ambu se utilizan en el grupo de un solo uso.
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Comparador activo: 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.
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Reusable diagnostic gastroscopes from Olympus are used in the reusable group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Endoscopist-rated composite usability score
Periodo de tiempo: Procedure day (immediately after completion of the procedure)
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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.
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Procedure day (immediately after completion of the procedure)
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Cost per gastroscopy during the single-use period compared with the reusable period
Periodo de tiempo: During the gastroscopy procedure and completion of all procedure-related activities (same day).
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Cost per gastroscopy (EUR) will be calculated for each study period using hospital administrative and procedural data. The calculation will include:
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During the gastroscopy procedure and completion of all procedure-related activities (same day).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Technical success of single-use gastroscopes vs reusable gastroscopes
Periodo de tiempo: During the procedure
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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.
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During the procedure
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Cross-over rate
Periodo de tiempo: During the procedure
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Frequency of gastroscopies requiring cross-over to another gastroscope
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During the procedure
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Frequency of predefined endoscopic findings
Periodo de tiempo: During the procedure
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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.
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During the procedure
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Complications
Periodo de tiempo: 24 hours and 72 hours follow-up after the procedure
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Complications related to gastroscopy
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24 hours and 72 hours follow-up after the procedure
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30-day mortality
Periodo de tiempo: 30 days after the procedure
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Mortality within 30 days after the procedure
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30 days after the procedure
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Duration of procedure
Periodo de tiempo: During the procedure
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The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
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During the procedure
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Technical success rate of therapeutic endoscopic procedures
Periodo de tiempo: During the procedure
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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.
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During the procedure
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Diagnostic adequacy rate of endoscopic biopsies
Periodo de tiempo: After completion of the pathology examination (up to 2 months after the procedure)
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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.
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After completion of the pathology examination (up to 2 months after the procedure)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Lasse Bremholm Hansen, PhD,ass.prof, Surgical department of Zealand University Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Luo X, Ji M, Zhang S, Chen X, Zong Y, Zhang X, Hu H, Hao X, Shao L, Sun C, Shi H, Wang J, Wang B, Li P. Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial. Gastrointest Endosc. 2022 Aug;96(2):250-261. doi: 10.1016/j.gie.2022.03.024. Epub 2022 Apr 4.
- Li DF, Shi RY, Tian YH, Xu ZL, Zhou YS, Sun XJ, Cai JW, Fang YY, Peng H, Wang JM, Dong T, Cai YD, Yao J, Wang LS. The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial. Z Gastroenterol. 2022 Sep;60(9):1314-1319. doi: 10.1055/a-1555-0568. Epub 2021 Nov 12.
- van der Ploeg K, de Jonge PJF, Lammers WJ, Koch AD, Vos MC, Paulsen V, Aabakken L, Bruno M. Performance of a single-use gastroscope for esophagogastroduodenoscopy: Prospective evaluation. Endosc Int Open. 2024 Mar 18;12(3):E428-E434. doi: 10.1055/a-2271-2303. eCollection 2024 Mar.
- Ebigbo A, Tadic V, Schlottmann J, Braun G, Prinz F, Wanzl J, Ayoub M, Kraus L, Scheppach M, Nagl S, Schnoy E, Weber T, Probst A, Messmann H, Rommele C. Evaluation of a single-use gastroscope in patients presenting with suspected upper gastrointestinal hemorrhage: a pilot feasibility study (One-Scope I). Endoscopy. 2023 Oct;55(10):940-944. doi: 10.1055/a-2089-5969. Epub 2023 May 9.
- Han ZL, Lin BT, Wang ZJ, Chen X, Xi YY, Wang JF, Qiao WG, Huang Y, Lin ZZ, Huang SH, Chua TY, Liu SD, Luo XB. Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos). Dig Endosc. 2023 Nov;35(7):857-865. doi: 10.1111/den.14548. Epub 2023 Apr 5.
- Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30.
- Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available.
- Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar.
- Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17.
- Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9.
- Rommele C, Ayoub M, Scheppach MW, Muzalyova A, Wanzl J, Tadic V, Braun G, Weber T, Roser D, Nagl S, Messmann H, Ebigbo A. Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial. Endoscopy. 2026 May;58(5):481-490. doi: 10.1055/a-2735-1114. Epub 2025 Oct 29.
- Weusten BLAM, Bisschops R, Dinis-Ribeiro M, di Pietro M, Pech O, Spaander MCW, Baldaque-Silva F, Barret M, Coron E, Fernandez-Esparrach G, Fitzgerald RC, Jansen M, Jovani M, Marques-de-Sa I, Rattan A, Tan WK, Verheij EPD, Zellenrath PA, Triantafyllou K, Pouw RE. Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2023 Dec;55(12):1124-1146. doi: 10.1055/a-2176-2440. Epub 2023 Oct 9.
- Rommele C, Ayoub M, Wanzl J, Tadic V, Braun G, Weber T, Scheppach MW, Roser D, Matic K, Nagl S, Messmann H, Ebigbo A. Clinical evaluation of a novel single-use therapeutic gastroscope: a pilot feasibility study. Endoscopy. 2025 Apr;57(4):339-344. doi: 10.1055/a-2436-7933. Epub 2024 Oct 8.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de julio de 2026
Finalización primaria (Estimado)
30 de octubre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de julio de 2026
Publicado por primera vez (Actual)
27 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SUSUES_endoscopyunit
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .