Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
NCT ID: NCT02221076
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2014-07-31
2016-04-18
Brief Summary
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Detailed Description
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The confocal miniprobe will be positioned against the surface of these organs or inside these same organs if the tumor is intratissular through a needle, and sequences will be acquired. Final diagnosis will be obtained for the patient, either through the result of the biopsies or through surgical pathology if the patient's lesion is surgically resected. Then imaging will be performed as well ex vivo on the resected specimens to provide additional stable imaging, and compare image quality to in vivo imaging.
The clinical endpoints of the study are:
* One or several Confocal Miniprobe designs optimized for use during colposcopy and hysteroscopy
* An optimized protocol of operations when using the designed Confocal Miniprobes during colposcopy and hysteroscopy as well as in the surgical setting, robotized or not (staining, use of accessories to hold the probes, etc...)
* A first atlas of endomicroscopic images obtained in the cervix, endocervix and endometrium
* The number, type and severity of recorded adverse events (to evaluate the safety).
Final objectives of CLE in gynecology:
* During colposcopic examination of the exocervix and conization, CLE is intended to be used to target biopsy and guide resection.
* During hysteroscopic examination of the endocervix, CLE is intended to be used to target biopsy and guide resection. Its ability to diagnose endocervical cancer will be evaluated.
* For endometrium cancer, CLE is to be used to target biopsy during hysteroscopy procedures and to evaluate cancer extension by examining lymphe node invasion during surgical procedures.
* During adjuvant surgery, the cervix is to be imaged by CLE to describe area altered by radio-chemotherapy.
* Ovaries and tubes are to be imaged by CLE before chemotherapy to diagnose cancer and after chemotherapy to detect residual tumor or fibrosis.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Confocal Laser Endomicroscopy (CLE)
The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs.
Confocal Laser Endomicroscopy (CLE)
Real-time microscopic imaging of living tissue during the standard procedure
Interventions
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Confocal Laser Endomicroscopy (CLE)
Real-time microscopic imaging of living tissue during the standard procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for a hysteroscopy
* Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
* 18 years or older.
Exclusion Criteria
* Previous life-threatening allergic reactions and known hypersensitivity
* Pregnancy or breast-feeding
* History of cardio-pulmonary disease (including bronchial asthma)
* Restricted renal function
* Patients under a beta-blockers treatment
18 Years
FEMALE
No
Sponsors
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Mauna Kea Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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ERIC LAMBAUDIE
Role: PRINCIPAL_INVESTIGATOR
IPC, Marseille, France
Locations
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Institut Paoli Calmettes
Marseille, , France
Countries
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Other Identifiers
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2014-A00312-45
Identifier Type: OTHER
Identifier Source: secondary_id
GYN_MKT_2014
Identifier Type: -
Identifier Source: org_study_id
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