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)
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.
Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months, we will conduct blinded reviews of the images to determine new sets of brightness numbers.
Jerome L Belinson, MD
Preventive Oncology International
China: Ethics Committee