Optical Biopsy in Gynecological Surgery

Overview

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

Full Title of Study: “Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 29, 2025

Interventions

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

Arms, Groups and Cohorts

  • Experimental: group using Cellvizio® optical biopsy

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gautier CHENE, MD, Principal Investigator, Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
  • Overall Contact(s)
    • Gautier CHENE, MD, (4) 72 35 58 70, gautier.chene@chu-lyon.fr

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