- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: KUNSHAN HE
- Numéro de téléphone: +86 18500535530
- E-mail: hekunshan@buaa.edu.cn
Lieux d'étude
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Beijing, Chine
- Institute of Automation, Chinese Academy of Sciences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Completion rate of qualified intraoperative surgical imaging data
Délai: Immediately after each surgery
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Immediately after each surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Completeness rate of long-term postoperative clinical follow-up
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- VISION
Informations sur les médicaments et les dispositifs, documents d'étude
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