About the IMPROVE-COLPO Clinical Study
The unique study design was employed to establish the baseline of how standard colposcopy was practiced by 160 physicians in 44 clinics using current binocular colposcopes. This retrospective chart review demonstrated the variability in compliance to colposcopy treatment guidelines and very low disease detection. The prospective arm of the study used the DYSIS colposcope – which standardizes the examination and measures the degree of acetowhitening in cervical tissue – creating a color-coded map to highlight the most acetowhite areas. The patient exams were matched by provider – one retrospective exam with their standard colposcope to one prospective exam with DYSIS.
In a sub-group population of 3,000 women with borderline Pap smears/high-risk HPV (the most difficult cases to assess visually because lesions are typically small), the DYSIS colposcope demonstrated a 51% increased detection rate for high-grade lesions overall. Moreover, detection of CIN3+ increased 73% over standard colposcopy. Both are statistically and clinically significant. This was done with fewer biopsies that yielded negative results. The DYSISmap-directed biopsies were 55.8% more likely to yield high grade disease than biopsies identified with a standard colposcope.
DYSIS Medical, Ltd. announced today that the prospective IMPROVE-COLPO clinical study, the first large scale study of community colposcopy practices, has enrolled more than 7,000 patients in 44 community clinics in the United States and reached statistical significance in its primary endpoint. Interim data from the study will be presented at the 2017 ACOG (American College of Obstetricians and Gynecologists) Annual Clinical and Scientific Meeting being held May 6-9 in San Diego, CA.
The study’s endpoint – to detect increased high grade cervical dysplasia with the use of the DYSIS colposcope compared to matched provider data using a standard colposcope – demonstrated clinically and statistically significant increases in detection rates for high-grade lesions overall and CIN3+ (the immediate pre-cursor to invasive cancer) over standard colposcopy. This was done with fewer biopsies that yielded negative results.
DYSIS Medical’s CEO Alastair Atkinson commented, “The IMPROVE-COLPO study demonstrates the outstanding clinical outcomes generated by the DYSIS cervical map and will no doubt help clinicians better stratify risk and follow patients appropriately.”