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 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

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Key information

Conditions

Gynecologic Surgical Procedures Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon, Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cellvizio®

Device

use of the Cellvizio® optical biopsy

Primary outcomes

correlation optical biopsy and anatomopathology

Time frame: day 0

The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Gautier CHENE, MD

CONTACT

[email protected]

(4) 72 35 58 70 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

Acronym: GYNECOPTIC

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Nov 6, 2019
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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