Optical Biopsy in Gynecological Surgery

Gynecologic Surgical Procedures Clinical Trial

— GYNECOPTIC  

Official title:

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154683
• Other study ID #: 69HCL18_0945
• Secondary ID: 2019-A01724-53
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: June 29, 2025

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Gautier CHENE, MD
• Phone: (4) 72 35 58 70
• Email: gautier.chene[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 29, 2025
• Est. primary completion date: June 29, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Surgical Procedures

Intervention

Device:
• Cellvizio®
use of the Cellvizio® optical biopsy

Locations

Country	Name	City	State
France	Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon	Bron
France	Service de Gynécologie, HFME, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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