- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: KUNSHAN HE
- Phone Number: +86 18500535530
- Email: hekunshan@buaa.edu.cn
Study Locations
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Beijing, China
- Institute of Automation, Chinese Academy of Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Completion rate of qualified intraoperative surgical imaging data
Time Frame: Immediately after each surgery
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Immediately after each surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Completeness rate of long-term postoperative clinical follow-up
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VISION
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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