Status:
COMPLETED
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
Lead Sponsor:
Mauna Kea Technologies
Conditions:
Cervix Cancer
Endometrium Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicr...
Detailed Description
This is a prospective study: about 75 patients (25 for each pathology) scheduled for a colposcopy or hysteroscopy examination or for a surgical treatment of the cervix/endocervix/endometrium/ovarian o...
Eligibility Criteria
Inclusion
- Patients scheduled for a colposcopy
- Patients scheduled for a hysteroscopy
- Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
- 18 years or older.
Exclusion
- Allergy to fluorescein
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02221076
Start Date
July 1 2014
End Date
April 18 2016
Last Update
August 29 2017
Active Locations (1)
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1
Institut Paoli Calmettes
Marseille, France, 13273