Gynecologic Surgical Procedures
Conditions
Keywords
salpingectomy, Cellvizio®, optical biopsy, unilateral or bilateral salpingectomy, ovariectomy, Endometriosis, surgery for cervical, ovarian cancer
Brief 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 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
Interventions
DEVICECellvizio®
use of the Cellvizio® optical biopsy
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 treatment * Inability to understand information provided * Not covered by a national health insurance scheme, prisoner or under administrative supervision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation optical biopsy and anatomopathology | day 0 | The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGautier CHENE, MD
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
Outcome results
None listed