Optical Biopsy and Fallopian Tube (FALLOPTIC)

September 5, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bilateral laparoscopic salpingectomy
Procedure: bilateral laparoscopic salpingectomy
Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy
Device: endomicroscopy Cellvizio® system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
Time Frame: DAY 1
DAY 1

Secondary Outcome Measures

Outcome Measure
Time Frame
: Description of the optical biopsy pictures in order to state a classification
Time Frame: DAY 1
DAY 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimated)

February 19, 2015

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014.875

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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