Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- correlation optical biopsy and anatomopathology
研究概览
简要总结
Optical biopsy is a new technology that generates a real-time, cell-based, high-resolution view and analysis of tissues. Observation is instantaneous and non-invasive. This allows reliable and fast diagnosis which facilitates decision making as well as patient management.
The investigator have already conducted a feasibility study on the use of this new technology to evaluate ovarian and tubal pre-cancerous lesions in laparoscopy. In this new study, he wants to continue investigations, expand its use to other gynecological pathologies, and demonstrate the benefit of such a non-invasive technology in gynecology on the one hand in the diagnosis of lesions but also to appreciate the margins as accurately as possible surgical excision of tumors and / or endometriosis lesions.
The investigator have set up a prospective monocentric descriptive study. The hypothesis is that optical biopsy by Cellvizio® allows to observe in real time microscopically tissues and to characterize them in the field of gynecological surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or more
- •Informed and signed consent
- •Planned surgery under laparoscopy and included in the list below:
- •unilateral or bilateral salpingectomy
- •hysterectomy
- •ovariectomy
- •surgery of endometriosis
- •surgery for cancer of the cervix, endometrium, ovaries
排除标准
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •Pregnancy or desire of pregnancy during the study period, breastfeeding
- •Hypersensitivity to Fluorescein or any of its excipients
- •History of life-threatening reaction during angiography
- •Known allergic reactions and hypersensitivity
- •Severe asthma, heart and / or lung disease, diabetes
- •Person on beta-blocker treatment
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision
研究组 & 干预措施
group using Cellvizio® optical biopsy
干预措施: Cellvizio® (Device)
结局指标
主要结局
correlation optical biopsy and anatomopathology
时间窗: day 0
The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.
次要结局
未报告次要终点