Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
NCT02221076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2017-08-29
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 endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
Conditions
- Cervix Cancer
- Endometrium Cancer
- Ovarian Cancer
- Carcinoma in Situ of Fallopian Tube
Interventions
- DEVICE
-
Confocal Laser Endomicroscopy (CLE)
Real-time microscopic imaging of living tissue during the standard procedure
Sponsors & Collaborators
-
Mauna Kea Technologies
lead INDUSTRY
Principal Investigators
-
ERIC LAMBAUDIE · IPC, Marseille, France
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2016-04-18
- Completion
- 2016-04-18
Countries
- France
Study Locations
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