Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix (PUSHOCTII)
Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine cervix can differentiate between grades of pre-invasive and invasive cervical disease and cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to detect pre-invasive cervical disease and cervical cancer.
B. Specific Aims
1. Primary. To determine the sensitivity, specificity, positive and negative predictive
values for Niris 1300e OCT enhanced gynecologic examination (VIA-OCT
vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical
intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.
2. Secondary. To examine the ease of use of Niris 1300e OCT in a real time clinical setting
in order to assess its potential application during a "see and treat" or "single episode
of care" clinic visit.
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