Optical Biopsy in Gynecological Surgery
Recruiting · NCT04154683 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospices Civils de Lyon
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
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
Where it is running
2 locations listed.
- Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon - Bron, France
- Service de Gynécologie, HFME, Hospices Civils de Lyon - Bron, France