Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit
27 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
300
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Camilla Kjelkvist-Born, MD
- Número de telefone: +4528263875
- E-mail: camkj@regionsjaelland.dk
Estude backup de contato
- Nome: Marie Louise Malmstrøm, MD, PhD
- E-mail: malmstroem@gmail.com
Locais de estudo
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Køge, Dinamarca, 4600
- Recrutamento
- Zealand University Hospital
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Contato:
- Camilla Kjelkvist-Born, MD
- Número de telefone: +4528263875
- E-mail: camkj@regionsjaelland.dk
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Contato:
- Marie Louise Malmstrøm, MD, PhD
- E-mail: malmstroem@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Elective or subacute gastroscopy in the endoscopy unit
- Age ≥ 18 years
Exclusion Criteria:
- Surveillance gastroscopy for Barrett's esophagus
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Os gastroscópios descartáveis com marcação CE da Ambu são utilizados no grupo de uso único.
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Endoscopist-rated composite usability score
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Technical success of single-use gastroscopes vs reusable gastroscopes
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Lasse Bremholm Hansen, PhD,ass.prof, Surgical department of Zealand University Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
27 de julho de 2026
Conclusão Primária (Estimado)
30 de outubro de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
15 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de julho de 2026
Primeira postagem (Real)
27 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SUSUES_endoscopyunit
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .