RecruitingNot ApplicableNCT04154683

Optical Biopsy in Gynecological Surgery

Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery


Sponsor

Hospices Civils de Lyon

Enrollment

80 participants

Start Date

Jun 29, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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

Interventions

DEVICECellvizio®

use of the Cellvizio® optical biopsy


Locations(2)

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, France

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, France

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NCT04154683