Optical Biopsy in Gynecological Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospices Civils de Lyon

About this trial

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 criteria

Qualifiers

Women aged 18 years or more

Informed and signed consent

unilateral or bilateral salpingectomy

hysterectomy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cellvizio®

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators