Optical Biopsy in Gynecological Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cellvizio®.
- Who it may be relevant to
- Registry conditions: Gynecologic Surgical Procedures. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
Overview
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
Interventions
- Device Cellvizio®
use of the Cellvizio® optical biopsy
Primary outcome measures
- correlation optical biopsy and anatomopathology [Time frame: day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon — Bron
- Service de Gynécologie, HFME, Hospices Civils de Lyon — Bron
Identifiers
NCT: NCT04154683 · 69HCL18_0945 · 2019-A01724-53