NCT04154683

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2020Jun 2026

First Submitted

Initial submission to the registry

November 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

November 5, 2019

Last Update Submit

January 14, 2026

Conditions

Gynecologic Surgical Procedures

Keywords

salpingectomyCellvizio®optical biopsyunilateral or bilateral salpingectomyovariectomyEndometriosissurgery for cervicalovarian cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 0

Study Arms (1)

group using Cellvizio® optical biopsy

EXPERIMENTAL
Device: Cellvizio®

Interventions

Cellvizio®DEVICE

use of the Cellvizio® optical biopsy

group using Cellvizio® optical biopsy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, 69500, France

NOT YET RECRUITING

Service de Gynécologie, HFME, Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

EndometriosisOvarian Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsEndocrine System DiseasesGonadal Disorders

Study Officials

  • Gautier CHENE, MD

    Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gautier CHENE, MD

CONTACT

(4) 72 35 58 70gautier.chene@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 6, 2019

Study Start

June 29, 2020

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

June 29, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(2)