Using optical biopsy technology in gynecological surgeries
Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
This study is testing a new technology called optical biopsy to see if it can help doctors better diagnose and treat tissue issues during gynecological surgeries for women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT04154683 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of optical biopsy technology, specifically Cellvizio®, to provide real-time, high-resolution analysis of tissues during gynecological surgeries. The aim is to enhance the diagnosis of lesions and improve surgical decision-making by accurately assessing tissue margins. The study builds on previous feasibility research and seeks to expand the application of this non-invasive technology to various gynecological conditions. It is a prospective monocentric descriptive study focusing on women undergoing laparoscopic surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are scheduled for laparoscopic surgeries such as salpingectomy, hysterectomy, or ovariectomy.
Not a fit: Patients who may not benefit from this study include those with significant postoperative risk factors, such as coagulation disorders or severe asthma.
Why it matters
Potential benefit: If successful, this technology could lead to faster and more accurate diagnoses during gynecological surgeries, improving patient outcomes.
How similar studies have performed: Other studies have shown promise with similar optical biopsy technologies, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron and 1 other locations
- Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon — Bron, France (Not_yet_recruiting)
- Service de Gynécologie, HFME, Hospices Civils de Lyon — Bron, France (Recruiting)
Study contacts
- Principal investigator: Gautier CHENE, MD — Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
- Study coordinator: Gautier CHENE, MD
- Email: gautier.chene@chu-lyon.fr
- Phone: (4) 72 35 58 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.