IMPROVE (US Clinical Study)
IMPROVE COLPO − Is the name of the clinical trial that DySIS Medical, Inc. is currently running to investigate the clinical performance of DySIS in comparison to conventional colposcopy. The study was approved by a central independent Institutional Review Board (Ethical and Independent Review Services, Corte Madera, CA) and is currenlty the largest clinical trial ever done in colposcopy with potentially 50 clinical sites and 9,000 subjects. Colposcopy is the procedure performed after an abnormal Pap smear to detect precancerous areas that may need early treatment to prevent cervical cancer. It is currently a very subjective process and studies have shown much variability between physicians performing this procedure.
The main objective of the “IMproved PRactice Outcomes and Value Excellence in Colposcopy” (IMPROVE-COLPO) study is to quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS Colposcope with Advanced Cervical Scan. Data and findings will be used for presentations, articles, health economics assessments and educating payers.
“The study will be a comprehensive two-arm community trial, which will collect data in an online registry from a range of different practices using DySIS across the USA reflecting “real life” colposcopy,” Clinical Manager, Dr. Manolis Papagiannakis commented. “This type of trial has never been done before in colposcopy, so little is known about standard community practice in the USA. We have had 2 large, multi-center European trials that have demonstrated excellent performance with the DySIS Advanced Cervical Imaging System, so we are very excited to demonstrate similar results with U.S. clinicians.
If you would like more details or are interested in joining the IMPROVE study please email here