Used with colposcopy: investigational device improves CIN 2, 3 detection.(Gynecology)

SAN DIEGO -- An investigational optical detection system used in conjunction with colposcopy increased the detection of high-grade cervical intraepithelial neoplasia by 26.5%, compared with colposcopy alone in the first randomized controlled trial of such a device.

"Widespread use of the optical detection system [ODS] with colposcopy could catch over 100,000 cases of CIN 2 and 3 that would otherwise have gone undetected," Dr. Michael Gold reported at the annual meeting of the Society of Gynecologic Oncologists.

In a study funded by MediSpectra Inc. of Lexington, Mass., which developed the ODS. researchers at 13 sites randomized 2,186 women with abnormal Pap smears to either standard colposcopy or ODS-aided colposcopy.

The optical system, which has not yet been submitted to the Food and Drug Administration for premarket approval, uses a combination of fluorescence, white-light backscattered spectroscopy, and video imaging to make a 12-second scan of a 25-mm area of the cervix.

The study participants underwent a speculum examination and a cervical wash with ascetic acid solution. The ODS was then used to take an optical scan of the cervix, explained Dr. Gold of the University of Oklahoma Health Sciences Center.

For the 1,096 women randomized to colposcopy alone, a routine colposcopy was performed.

For the 1,090 women in the colposcopy-plus-ODS arm, the captured digital image of the cervix was then superimposed on the colposcopic image, depicting the areas with the highest probability of CIN 2 or 3.