Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
研究概览
简要总结
Visualize surgical needles inserted in the prostate, under the ultrasound modality.
详细描述
In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images.
We have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service.
The main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •of-age patient
- •patient for whom a radical prostatectomy is planned
- •patient with a prostate volume between 30g and 100g
- •patient affiliated to the social security or equivalent
- •Written informed consent
排除标准
- •contraindication
- •patient who has undergone a significant prostate resection
- •patient who has undergone a prostate irradiation
- •patient concerned by the L1121-6 à 8 of the health public code
研究组 & 干预措施
medical device
medical device to acquire ultrasound and endoscopic images during surgery
干预措施: Software for acquiring ultrasound and endoscopic images (Device)
结局指标
主要结局
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
时间窗: 1year
次要结局
- Percent of mistaken segmentation of the vesical neck in the endoscopic image(1year)
- Percent of data(ultrasound and endoscopic) on which the merging works(1year)
- Percent of accurate merging(1year)
研究者
AdministrateurCIC
principal investigator
University Hospital, Grenoble