Optical Biopsy in Gynecological Surgery

Not Applicable

Recruiting

• Conditions: Gynecologic Surgical Procedures
• Interventions: Device: Cellvizio®

• Registration Number: NCT04154683
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Study Start: 2020-06-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-06-29
• Study Completion: 2025-06-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group using Cellvizio® optical biopsy	Cellvizio®	-

Primary Outcome Measures

Name	Time	Method
correlation optical biopsy and anatomopathology	day 0	The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.

Trial Locations

Locations (2)

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

Service de Gynécologie, HFME, Hospices Civils de Lyon; 🇫🇷 Bron, France