NCT06762613已完成不适用
Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI
Wuhan Union Hospital, China3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Number of puncture needles of participants for GPS and CBCT-guided lung puncture procedures.
研究概览
简要总结
The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:
- Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
- Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.
Participants will:
- Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
- The images of CBCT will be collected
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
- •Participants with pre-operation CT images available.
- •Participants whose physical condition is suitable for PLP.
排除标准
- •Participants have metallic implants in the body, which severely affects the image quality.
- •Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- •Participants are pregnant or breastfeeding.
- •Participants are unwilling or unable to sign informed consent.
结局指标
主要结局
Number of puncture needles of participants for GPS and CBCT-guided lung puncture procedures.
时间窗: From enrollment to the end of the lung puncture procedure.
The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.
次要结局
- Radiation dose for GPS and CBCT-guided lung puncture procedures.(From enrollment to the end of the lung puncture procedure.)
- Puncture time for GPS and CBCT-guided lung puncture procedures.(From enrollment to the end of the lung puncture procedure.)
- Intraoperative and postoperative complications of participants for GPS and CBCT-guided lung puncture procedures.(From enrollment to the end of the lung puncture procedure at 1 week.)
研究者
研究点 (3)
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