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Optical Biopsy in Gynecological Surgery (GYNECOPTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154683
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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


Condition or disease Intervention/treatment Phase
Gynecologic Surgical Procedures Device: Cellvizio® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : June 29, 2021
Estimated Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: group using Cellvizio® optical biopsy Device: Cellvizio®
use of the Cellvizio® optical biopsy




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154683


Contacts
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Contact: Gautier CHENE, MD (4) 72 35 58 70 ext +33 gautier.chene@chu-lyon.fr

Locations
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France
Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon Not yet recruiting
Bron, France, 69500
Contact: Gautier CHENE, MD    (4) 72 35 58 70 ext +33    gautier.chene@chu-lyon.fr   
Principal Investigator: Gautier CHENE, MD         
Sub-Investigator: Gery LAMBLIN, MD         
Sub-Investigator: Philippe Chabert, MD         
Sub-Investigator: Karine Lebail-Carval, MD         
Sub-Investigator: Erdogan Nohuz, MD         
Service de Gynécologie, HFME, Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Gautier CHENE, MD       gautier.chene@chu-lyon.fr   
Principal Investigator: Gautier CHENE, MD         
Sub-Investigator: Philippe CHABERT, MD         
Sub-Investigator: Géry LAMBLIN, MD         
Sub-Investigator: Karine Lebail-Carval, MD         
Sub-Investigator: Erdogan Nohuz, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gautier CHENE, MD Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04154683    
Other Study ID Numbers: 69HCL18_0945
2019-A01724-53 ( Other Identifier: ID-RCB )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
salpingectomy
Cellvizio®
optical biopsy
unilateral or bilateral salpingectomy
ovariectomy
Endometriosis
surgery for cervical
ovarian cancer