DYSIS Medical Gains Approval for Largest Ever Colposcopy Trial
DYSIS Medical gains approval to begin the largest U.S. colposcopy clinical trial ever attempted
Tampa, FL – 22 July 2014 − DYSIS Medical, Inc., announced today that it has been approved by a central independent Institutional Review Board (Ethical and Independent Review Services, Corte Madera, CA) to begin enrollment in 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.1,2, 3, 4, 5
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. 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.
Kim Stebbings, U.S. President stated, “DYSIS has gained excellent traction in the US market over the last 6 months but we believe it’s important to demonstrate the value that our technology can deliver in the real-world clinical environment – the positive impact it can have on patients and the benefits for the practice”.
DYSIS Medical, a medical devices company active within Women’s Health, has developed an advanced cervical scan which, in addition to performing traditional colposcopy examinations, uses dynamic spectral imaging to scan, quantify and map the cervix. Initial sites have been identified and enrollment in the IMPROVE-COLPO Study is planned to begin in August.
1 Jeronimo, Schiffman, Amer J of OB & Gyn, 2006; 2 Massad, Collins, Gyn Oncol, 2003; 3 Wu, J of Gyn and Obstetrics, 2005; 4 ALTS Trial, Am J of Obstetrics and Gynecology, 2003; 5 Massad, J Low Genit Tract Dis. 2009 July
DYSIS Medical, Inc. Tel: +813-367-3564
DYSIS Medical Ltd
DYSIS Medical Ltd has its global headquarters in Edinburgh. 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
The DYSIS product employs advanced photonics and computer assistance to quantify and map the cervix during the aceto-whitening process. The product is CE marked and commercially available in Europe. It is also cleared to market in the USA by the FDA under the 510(k) programme as a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.