Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04154683

Optical Biopsy in Gynecological Surgery

Led by Hospices Civils de Lyon · Updated on 2026-01-15

80

Participants Needed

2

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

Optical Biopsy in Gynecological Surgery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years or more
  • Informed and signed consent
  • Planned surgery under laparoscopy including unilateral or bilateral salpingectomy, hysterectomy, ovariectomy, surgery of endometriosis, or surgery for cancer of the cervix, endometrium, or ovaries
Not Eligible

You will not qualify if you...

  • Disorder causing unacceptable risk of postoperative complications such as coagulation or immune system disorders or progressive disease
  • Pregnancy, desire for pregnancy during study period, or breastfeeding
  • Hypersensitivity to fluorescein or any excipients
  • History of life-threatening reaction during angiography
  • Known allergic reactions and hypersensitivity
  • Severe asthma, heart or lung disease, diabetes
  • Treatment with beta-blockers
  • Inability to understand provided information
  • Not covered by national health insurance, prisoner, or under administrative supervision

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, France, 69500

Not Yet Recruiting

2

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, France, 69500

Actively Recruiting

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Research Team

G

Gautier CHENE, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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