跳至主要内容
临床试验/NCT07397000
NCT07397000招募中不适用

Development of AI-Based Approaches for Automated Real-Time Detection of Surgical Smoke Using Endoscopic Image and Video Data

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Detection of surgical smoke gas

研究概览

简要总结

The goal of this observational, prospective monocentric pilot study is to generate a pilot dataset to train a computer-assisted model for automatic, intraoperative detection of surgical smoke gas.

Women with indications for laparoscopic evaluation requiring the use of HF surgery (expecting the formation of smoke gas) and a smoke evacuation system (Karl Storz S-Pilot) are employed.

详细描述

Detection of surgical smoke gas with an accuracy F1 score of >= 0.8 on test datasets. The activation of the S-Pilot by clinic personnel will be used as the gold standard.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • - Age ≥ 18 years
  • Written consent after receiving information
  • Indication for surgical treatment using HF surgery

排除标准

  • - Expected lack of compliance by the patient or inability of the patient to understand the meaning and purpose of the clinical trial
  • Lack of patient consent
  • S-Pilot cannot be used

结局指标

主要结局

Detection of surgical smoke gas

时间窗: At the end of the study (9 months)

Detection of surgical smoke gas with an accuracy of an F1 score of ≥ 0.8 on test data sets.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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