The phase I results show that a non contact optical device, the ColpoProbe , achieved outcomes comparable with pathology, in staging pre-cancerous disease development in the human cervix. The ColpoProbe illuminates tissue, records light returned from the tissue and correlates fluorescence and backscatter to its histopathology database. The ultimate objective is a commercial device providing the physician with real time in-vivo pathology. The phase II program aims to improve the current device and determine its clinical efficacy. A variety of optical readings will be taken from two hundred patients, with positive Pap smears, at the Beth Israel Hospital. The Phase I algorithm will be improved. A training set will be crated and tested using various statistical techniques. Optical readings will be taken from the cervices of healthy volunteers to determine the effect of acetic acid application and the menstrual cycle. We will also investigate if the ColpoProbe can determine the presence of human papilloma viruses. A commercial ColpoProbe promises a half billion dollar reduction at the costs of follow up from a positive Pap smear. These savings will result from a reduction in the number of biopsies and referrals. Phase III funds are secured upon achieving the Phase II goals.
There are several areas where a successful ColpoProbe would be clinically useful. A ColpoProbe(TM), in scanning the cervix, would give the determination needed for the physician to resolve the uncertainty created by the atypical (ASCUS) report. The device will further facilitate the """"""""see and treat"""""""" option for high-grade lesions and with patients where repeat visit compliance is likely to be poor.
