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
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:KUNSHAN HE
- 電話番号:+86 18500535530
- メール:hekunshan@buaa.edu.cn
研究場所
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Beijing、中国
- Institute of Automation, Chinese Academy of Sciences
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Completion rate of qualified intraoperative surgical imaging data
時間枠:Immediately after each surgery
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Immediately after each surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Completeness rate of long-term postoperative clinical follow-up
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- VISION
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。