- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07752862
Prospective Collection and Registry Study of Multicenter, Multidisciplinary Surgical Minimally Invasive Videos (VISION)
Prospective Observational Cohort Study on the Construction of Standardized Video Datasets for Multicenter, Multidisciplinary Minimally Invasive Laparoscopic and Robotic Surgery and Their Application in the Development of Surgical AI Large Models
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: KUNSHAN HE
- Número de telefone: +86 18500535530
- E-mail: hekunshan@buaa.edu.cn
Locais de estudo
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Beijing, China
- Institute of Automation, Chinese Academy of Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients aged ≥ 18 years old hospitalized to receive minimally invasive endoscopic, laparoscopic or robotic surgical treatment for diseases of various body systems;
- Complete full-length intraoperative surgical videos can be recorded during operation, with complete medical records and preoperative imaging data;
- Participants fully understand the study, voluntarily sign written informed consent, and agree that their de-identified intraoperative images and clinical data can be used for scientific research.
Exclusion Criteria:
- Minors under 18 years of age;
- Patients with incomplete intraoperative videos or missing clinical imaging documents;
- Patients with consciousness disturbance or mental disorders who cannot sign informed consent independently;
- Subjects who refuse to participate in the study and disapprove the use of their medical data for research;
- Patients who are predicted to be unavailable for long-term postoperative follow-up.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Completion rate of qualified intraoperative surgical imaging data
Prazo: Immediately after each surgery
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Immediately after each surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Completeness rate of long-term postoperative clinical follow-up
Prazo: 3 months, 1 year, 3 years and 5 years after surgery
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3 months, 1 year, 3 years and 5 years after surgery
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Reusability rate of annotated key anatomical structures in videos
Prazo: From completion of data warehousing and annotation, the reusability rate will be analyzed within 3 months, assessed up to 3 months after annotation completion.
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From completion of data warehousing and annotation, the reusability rate will be analyzed within 3 months, assessed up to 3 months after annotation completion.
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Feasibility rate (%) of surgical video dataset applied in different clinical AI research scenarios
Prazo: After full construction of the surgical video dataset, scenario feasibility assessment will be finished within 6 months, assessed up to 6 months after dataset construction.
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Three core application scenarios are predefined: 1) training of surgical computer vision AI models; 2) validation of intraoperative surgical recognition algorithms; 3) surgical skill assessment and teaching research. An expert review panel consisting of at least 3 attending surgeons and 2 medical AI researchers independently evaluates whether the dataset has sufficient sample size, annotation completeness and video quality to support each scenario. Feasibility proportion is calculated as: (Number of scenarios the dataset is suitable for / Total predefined scenarios) × 100%. |
After full construction of the surgical video dataset, scenario feasibility assessment will be finished within 6 months, assessed up to 6 months after dataset construction.
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Accuracy percentage (%) of AI-based surgical procedure identification on annotated surgical videos
Prazo: After completion of data warehousing and annotation, AI surgical procedure identification accuracy testing will be conducted within 3 months, assessed up to 3 months post annotation completion.
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After all surgical videos are imported into the data warehouse and manually annotated by experienced surgeons to generate gold-standard procedure labels, the surgical video analysis AI model automatically outputs predicted surgical procedure categories for each video clip. Each AI-predicted label is compared against the manual gold-standard annotation label. Identification accuracy is calculated by the formula: (Number of video clips with correctly predicted surgical procedures / Total number of tested video clips) × 100%. |
After completion of data warehousing and annotation, AI surgical procedure identification accuracy testing will be conducted within 3 months, assessed up to 3 months post annotation completion.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- VISION
Informações sobre medicamentos e dispositivos, documentos de estudo
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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 .