Actively Recruiting
Diagnostic Performance of Optical Biopsy by Cellvizio42 in Gynecological Surgery
Led by Hospices Civils de Lyon · Updated on 2026-01-15
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of a new technology called optical biopsy by Cellvizio42, which provides a real-time, high-resolution view and analysis of tissue cells. The study focuses on gynecological surgeries to evaluate lesions and improve diagnosis and management, especially for pre-cancerous and other gynecological pathologies. The goal is to demonstrate how this non-invasive technology helps identify lesions and assess tumor or endometriosis excision margins accurately during surgery. The study involves the use of the Cellvizio42 device during laparoscopic surgeries such as salpingectomy, hysterectomy, ovariectomy, and surgeries for endometriosis or gynecological cancers of the cervix, endometrium, and ovaries. It is a prospective, single-center, descriptive study, where optical biopsy is performed intraoperatively to observe tissues microscopically in real time. Participants will undergo surgery with the optical biopsy device used to analyze tissue, and researchers will compare these observations with standard anatomopathological results collected on the day of surgery. The study monitors the correlation between optical biopsy findings and traditional pathology to evaluate diagnostic performance. Participation involves surgery and tissue analysis, with follow-up focusing on safety and diagnostic accuracy throughout the study duration.
CONDITIONS
Brief Title
Optical Biopsy in Gynecological Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or more
- Provided informed and signed consent
- Scheduled for laparoscopic surgery including unilateral or bilateral salpingectomy, hysterectomy, ovariectomy, surgery for endometriosis, or cancer surgery of the cervix, endometrium, or ovaries
You will not qualify if you...
- Presence of disorders that pose unacceptable risk of postoperative complications such as coagulation or immune system disorders
- Pregnancy, breastfeeding, or desire for pregnancy during the study period
- Hypersensitivity or allergy to Fluorescein or its excipients
- History of life-threatening reaction during angiography
- Severe asthma, heart or lung disease, diabetes
- Treatment with beta-blockers
- Inability to understand study 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo gynecological laparoscopic surgery during which the Cellvizio® optical biopsy device is used for diagnostic evaluation.
1 surgical visit (in-person)
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
Research Team
G
Gautier CHENE, MD
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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