Optical Biopsy in Gynecological Surgery

Study Overview
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Brief Summary
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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

Official Title
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Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

Conditions
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Gynecologic Surgical Procedures

Intervention / Treatment
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* Device: Cellvizio®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group using Cellvizio® optical biopsy<br> | Device: Cellvizio®<br>* use of the Cellvizio® optical biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation optical biopsy and anatomopathology | The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient. | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salpingectomy, Cellvizio®, optical biopsy, unilateral or bilateral salpingectomy, ovariectomy, Endometriosis, surgery for cervical, ovarian cancer