Clinical trial · Interventional
Optical Biopsy in Gynecological Surgery
Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellvizio® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- group using Cellvizio® optical biopsy
- interventionNames
- Device: Cellvizio®
Primary outcomes (1)
- measure
- correlation optical biopsy and anatomopathology
- timeFrame
- day 0
- description
- The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available