NCT04154683Completed
Optical Biopsy in Gynecological Surgery
Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 5 Nov 2019
- Start date
- 29 Jun 2020
- Primary completion date
- 28 Aug 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Endometriosis, Ovarian cancer
- NCT number
- NCT04154683
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 29 Jun 2020 to the primary completion date, 28 Aug 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- 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
Other
- Pregnancy or desire of pregnancy during the study period, breastfeeding
- Person on beta-blocker treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Gynécologie, HFME, Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon Coordinator of this site? Confirm its status | Bron | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.