Optical Biopsy in Gynecological Surgery

NCT ID: NCT04154683

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2026-06-29

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

Conditions

Gynecologic Surgical Procedures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

group using Cellvizio® optical biopsy

Group Type: EXPERIMENTAL

Cellvizio®

Intervention Type: DEVICE

use of the Cellvizio® optical biopsy

Interventions

Cellvizio®

use of the Cellvizio® optical biopsy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gautier CHENE, MD

Role: PRINCIPAL_INVESTIGATOR

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

Locations

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, , France

Site Status: NOT_YET_RECRUITING

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gautier CHENE, MD

Role: CONTACT

gautier.chene@chu-lyon.fr

(4) 72 35 58 70 ext. +33

Facility Contacts

Gautier CHENE, MD

Role: primary

gautier.chene@chu-lyon.fr

(4) 72 35 58 70 ext. +33

Gautier CHENE, MD

Role: primary

gautier.chene@chu-lyon.fr

Other Identifiers

2019-A01724-53

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0945

Identifier Type: -

Identifier Source: org_study_id