Optical Biopsy in Gynecological Surgery
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 feasi
| Condition(s) | Gynecologic Surgical Procedures |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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 Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Bron, France; Bron, France |
| Start date | 2020-06-29 |
| NCT ID | NCT04154683 |
| Official listing | https://clinicaltrials.gov/study/NCT04154683 |