Gynecologic Surgical ProceduresGYNECOPTICNCT04154683
Optical Biopsy in Gynecological Surgery
A study testing Cellvizio® in people with Gynecologic Surgical Procedures, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgical Procedures
- What is being tested?
- Cellvizio®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jun 2020to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Person on beta-blocker treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
Trial locations and contacts
2 sites in 1 country.
France2 sites
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
Bron, 69500
Service de Gynécologie, HFME, Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
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
- Gynecologic Surgical Procedures
- Being tested
- Cellvizio®
- Keywords
- salpingectomy, Cellvizio®, optical biopsy, unilateral or bilateral salpingectomy, ovariectomy, Endometriosis, surgery for cervical, ovarian cancer
- Medical subject headings
- Endometriosis, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellvizio®Device
use of the Cellvizio® optical biopsy
| Study group | Role | What they receive |
|---|---|---|
| group using Cellvizio® optical biopsy | Experimental | Not described Receives: Device: Cellvizio® |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation optical biopsy and anatomopathology
The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start29 Jun 2020
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier CHENE, MD, Principal investigator, Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154683
- Sponsor's protocol ID
- 69HCL18_0945
- Other IDs
- 2019-A01724-53
- Acronym
- GYNECOPTIC
- Status last verified
- Sep 2026
- First submitted
- 5 Nov 2019
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04154683
- Acronym / sponsor ID
- GYNECOPTIC / 69HCL18_0945
- Conditions
- Gynecologic Surgical Procedures
- Keywords
- salpingectomy, Cellvizio®, optical biopsy, unilateral or bilateral salpingectomy, ovariectomy, Endometriosis, surgery for cervical, ovarian cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group using Cellvizio® optical biopsy | Experimental | Device: Cellvizio® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 18 years or more
- Informed and signed consent
- Planned surgery under laparoscopy and included in the list below:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellvizio®use of the Cellvizio® optical biopsy | Device | group using Cellvizio® optical biopsy |
Primary outcome
correlation optical biopsy and anatomopathology
Time frame: day 0
The interpretation of the results of the optical biopsy will be compared with the interpretation of the pathological results for each patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gautier CHENE, MD principal investigator
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellvizio® in people with Gynecologic Surgical Procedures, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation optical biopsy and anatomopathology (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.