Optical Biopsy in Gynecological Surgery (GYNECOPTIC)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Gynecologic Surgical Procedures

Treatments: Device: Cellvizio®

Study type: Interventional

Funder types: Other

Identifiers

NCT04154683

69HCL18_0945

2019-A01724-53 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

group using Cellvizio® optical biopsy

Experimental group

Treatment:

Device: Cellvizio®