RecruitingNot ApplicableNCT04154683

Optical Biopsy in Gynecological Surgery

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery


Sponsor

Hospices Civils de Lyon

Enrollment

80 participants

Start Date

Jun 29, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a technique called "optical biopsy" during gynecological surgery, which uses a special fluorescent dye and imaging to examine tissue in real-time without needing to remove it. The goal is to see if this method can help surgeons better identify cancerous or abnormal tissue during laparoscopic procedures. **You may be eligible if...** - You are a woman aged 18 or older - You are scheduled for laparoscopic gynecological surgery, including procedures for endometriosis, removal of fallopian tubes or ovaries, hysterectomy, or surgery for cervical, uterine, or ovarian cancer **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to fluorescein (the dye used in the procedure) - You have a history of severe reactions during imaging procedures - You have severe asthma, serious heart or lung disease, or diabetes - You have an immune disorder or blood clotting problem Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECellvizio®

use of the Cellvizio® optical biopsy


Locations(2)

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, France

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, France

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NCT04154683


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