Optical Biopsy in Gynecological Surgery (GYNECOPTIC)

January 25, 2024 updated by: Hospices Civils de Lyon

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • France
      • Bron, France, 69500
        • Not yet recruiting
        • Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
        • Sub-Investigator:
          • Philippe CHABERT, MD
        • Contact:
        • Principal Investigator:
          • Gautier CHENE, MD
        • Sub-Investigator:
          • Géry LAMBLIN, MD
        • Sub-Investigator:
          • Karine LEBAIL-CARVAL, MD
        • Sub-Investigator:
          • Erdogan Nohuz, MD
      • Bron, France, 69500
        • Recruiting
        • Service de Gynécologie, HFME, Hospices Civils de Lyon
        • Sub-Investigator:
          • Philippe CHABERT, MD
        • Principal Investigator:
          • Gautier CHENE, MD
        • Sub-Investigator:
          • Géry LAMBLIN, MD
        • Sub-Investigator:
          • Karine LEBAIL-CARVAL, MD
        • Sub-Investigator:
          • Erdogan Nohuz, MD
        • Contact:

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:

  • 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

Exclusion Criteria:

  • 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group using Cellvizio® optical biopsy
Device: Cellvizio®
use of the Cellvizio® optical biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 0

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Gautier CHENE, MD, Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon

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 (Actual)

June 29, 2020

Primary Completion (Estimated)

June 29, 2025

Study Completion (Estimated)

June 29, 2025

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL18_0945
  • 2019-A01724-53 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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