DYSIS Makes Significant Progress in Largest Ever Colposcopy Trial
TAMPA, Fla., Jan. 15, 2015 /PRNewswire/ — With January being Cervical Health Awareness Month, DYSIS Medical announced today that over one third of its targeted enrollment is now under contract for its 50 site, 9000 patient colposcopy study.
Over 12,000 U.S. women are diagnosed with cervical cancer annually and 4,300 die from the disease. Colposcopy is the diagnostic procedure performed after an abnormal Pap smear to detect precancerous areas that may need early treatment to prevent invasive cervical cancer. Colposcopy is a very subjective procedure and studies have shown significant inaccuracy and variability in detecting high-grade pre-cancerous areas with standard colposcopy.1,2,3,4,5
The objective of the IMPROVE-COLPO Study is to measure outcome improvements with the DYSIS Advanced Cervical Imaging System compared to standard colposcopy. The FDA-cleared imaging procedure standardizes colposcopy and produces an intuitive color-coded map, similar to a weather map, to assist physicians in identifying, documenting and biopsying abnormal areas.
“We are excited about the significant progress made since the study approval in July 2014,” said Clinical Manager, Dr. Manolis Papagiannakis. “With over 34% of our sites already contracted, we expect to gain major insights into how standard colposcopy is performed and how DYSIS can improve care.”
IMPROVE study principal investigator, Jeff Livingston, MD of MacArthur Medical Center in Dallas commented, “After using the DYSIS Advanced Cervical Imaging System and seeing the clinical results, I don’t ever want to do colposcopy without DYSIS again. DYSISmap and the documentation images and tools for tracking, add real clinical value for me and my patients. DYSIS represents a technological advancement in the diagnosis and management of cervical dysplasia and cancer prevention.”
1 Jeronimo, Amer J of OB&GYN, 2006; 2 Massad, Gyn Oncol, 2003; 3 Wu, J of GYN&OB, 2005; 4 ALTS Trial, Am J of OB&GYN, 2003; 5Massad, J Low Genit Tract Dis. 2009
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DYSIS Medical Ltd
DYSIS Medical Ltd has its global headquarters in Edinburgh and US Headquarters in Tampa, FL. The company is committed to saving lives through the early detection and diagnosis of disease using biophotonic innovations. It aims to be the global leader in automated optical molecular imaging technologies for medical diagnostic and screening applications. For more information, please visit: www.dysismedical.com or call 844-DYSISMED.
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