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Optical Biopsy in Gynecological Surgery

Optical Biopsy in Gynecological Surgery

Recruiting
18 years and older
Female
Phase N/A

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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

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

Study details
    Gynecologic Surgical Procedures

NCT04154683

Hospices Civils de Lyon

29 January 2024

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