Ovarian Cancer Clinical Trial
Official title:
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
Verified date | August 2017 |
Source | Mauna Kea Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 18, 2016 |
Est. primary completion date | April 18, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli Calmettes | Marseille |
Lead Sponsor | Collaborator |
---|---|
Mauna Kea Technologies |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of participants with adverse events, their type and severity. | 8 months | ||
Secondary | Number of interpretable images per organ and per pathology | Each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc...). Thanks to this, a more complete atlas of images obtained gynaecological organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications. | 8 months |
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