Bilateral Laparoscopic SalpingectomyFALLOPTICNCT02365779
Optical Biopsy and Fallopian Tube
A study testing bilateral laparoscopic salpingectomy and endomicroscopy Cellvizio® system in people with Bilateral Laparoscopic Salpingectomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bilateral Laparoscopic Salpingectomy
- What is being tested?
- bilateral laparoscopic salpingectomy and endomicroscopy Cellvizio® system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Aug 2015
- 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
- Woman aged 18 years or more
- All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- Informed and signed consent
Who cannot join
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- Allergy to fluorescein
- Previous allergy or anaphylactic shock during an angiography
- Allergic or hypersensibility reactions
- Severe asthma, chronic cardiac or pulmonary diseases
Show all 10Show fewer
- Restricted renal function
- Patient under a beta-blockers treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon
Bron, 69500
About this study
Official title: Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).
The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.
Read the detailed description
Inclusion Criteria:
- Woman aged 18 years or more
- All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- Informed and signed consent
Exclusion Criteria:
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- Allergy to fluorescein
- Previous allergy or anaphylactic shock during an angiography
- Allergic or hypersensibility reactions
- Severe asthma, chronic cardiac or pulmonary diseases
- Restricted renal function
- Patient under a beta-blockers treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
- Conditions
- Bilateral Laparoscopic Salpingectomy
- Being tested
- bilateral laparoscopic salpingectomy, endomicroscopy Cellvizio® system
- Keywords
- salpingectomy, optical biopsy, Cellvizio®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral laparoscopic salpingectomyProcedure or surgery
Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy
endomicroscopy Cellvizio® systemDevice
| Study group | Role | What they receive |
|---|---|---|
| bilateral laparoscopic salpingectomy | Experimental | Not described Receives: Procedure: bilateral laparoscopic salpingectomy; Device: endomicroscopy Cellvizio® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
Measured: DAY 1
Secondary outcomes (1)
: Description of the optical biopsy pictures in order to state a classification
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bilateral Laparoscopic SalpingectomyStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365779
- Sponsor's protocol ID
- 2014.875
- Acronym
- FALLOPTIC
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2015
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Chene G, Chauvy L, Buenerd A, Moret S, Nadaud B, Beaufils E, Le Bail-Carval K, Chabert P, Mellier G, Lamblin G. In vivo confocal laser endomicroscopy during laparoscopy for gynecological surgery: A promising tool. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):565-569. doi: 10.1016/j.jogoh.2017.06.003. Epub 2017 Jun 23.
PubMed 28652089Chene G, Chauvy L, Buenerd A, Moret S, Nadaud B, Chabert P, Lamblin G. Dynamic real-time in vivo confocal laser endomicroscopy of the fallopian tube during laparoscopy in the prevention of ovarian cancer. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:18-23. doi: 10.1016/j.ejogrb.2017.07.002. Epub 2017 Jul 5.
PubMed 28692889
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy
- ClinicalTrials.gov ID
- NCT02365779
- Acronym / sponsor ID
- FALLOPTIC / 2014.875
- Conditions
- Bilateral Laparoscopic Salpingectomy
- Keywords
- salpingectomy, optical biopsy, Cellvizio®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).
The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.
Detailed description
Inclusion Criteria:
- Woman aged 18 years or more
- All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- Informed and signed consent
Exclusion Criteria:
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- Allergy to fluorescein
- Previous allergy or anaphylactic shock during an angiography
- Allergic or hypersensibility reactions
- Severe asthma, chronic cardiac or pulmonary diseases
- Restricted renal function
- Patient under a beta-blockers treatment
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bilateral laparoscopic salpingectomy | Experimental | Procedure: bilateral laparoscopic salpingectomy, Device: endomicroscopy Cellvizio® system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman aged 18 years or more
- All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
- Informed and signed consent
Key exclusion criteria (10 listed)
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- Pregnancy, ongoing or planned during the study period
- Allergy to fluorescein
- Previous allergy or anaphylactic shock during an angiography
- Allergic or hypersensibility reactions
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 |
|---|---|---|
| bilateral laparoscopic salpingectomyUse of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy | Procedure or surgery | bilateral laparoscopic salpingectomy |
| endomicroscopy Cellvizio® system | Device | bilateral laparoscopic salpingectomy |
Primary outcome
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
Time frame: DAY 1
1 secondary outcome
: Description of the optical biopsy pictures in order to state a classification
Time frame: DAY 1
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 11 Sep 2025.
- Results publication: PubMed 28652089Chene G, Chauvy L, Buenerd A, Moret S, Nadaud B, Beaufils E, Le Bail-Carval K, Chabert P, Mellier G, Lamblin G. In vivo confocal laser endomicroscopy during laparoscopy for gynecological surgery: A promising tool. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):565-569. doi: 10.1016/j.jogoh.2017.06.003. Epub 2017 Jun 23.
- Results publication: PubMed 28692889Chene G, Chauvy L, Buenerd A, Moret S, Nadaud B, Chabert P, Lamblin G. Dynamic real-time in vivo confocal laser endomicroscopy of the fallopian tube during laparoscopy in the prevention of ovarian cancer. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:18-23. doi: 10.1016/j.ejogrb.2017.07.002. Epub 2017 Jul 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral laparoscopic salpingectomy and endomicroscopy Cellvizio® system in people with Bilateral Laparoscopic Salpingectomy, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 10 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation (time frame: DAY 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365779, which also lists 2 linked publications.
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 11 Sep 2025.