Results from largest colposcopy trial published
Edinburgh, Scotland – October 3, 2017 – DYSIS Medical, Ltd. announced today the publication of the first article presenting results of the IMPROVE-COLPO study.
The IMPROVE-COLPO study was designed to observe how “real-world” colposcopy practice and patient outcomes change after the adoption of the DYSIS Colposcope in a wide setting of community-based colposcopy clinics in the USA. Between its two arms, the study recruited more than 7,500 women examined at 47 clinics (in 12 states) by 160 colposcopists, making it the largest colposcopy study ever undertaken. One arm collected results from women examined by standard colposcopy and the other arm with women examined with DYSIS Colposcopy.
The first paper presenting results from the study has been made available ahead-of-print by the Journal of Lower Genital Tract Disease. It analyzes and compares results achieved in a particular cohort of women (about 1,800 in each arm) who were referred for colposcopy following a Pap Smear result indicating a low-grade abnormality. Women with low-grade Pap results represent around 80% of all colposcopy referrals and yet sometimes harbor high-grade lesions that can be more difficult to detect.
The authors report a significant increase in the detection of women with precancerous lesions among those examined with DYSIS Colposcopy over those examined with standard methods. There were 31% more women detected with CIN2+ and 56% with CIN3+, introducing a significant improvement in the screening process. The detailed analysis includes the numbers of biopsies taken, and showed that the improved results were achieved with the same proportion of women undergoing biopsy, and only one additional biopsy taken per five patients. The authors concluded that, compared to standard biopsies, those taken with DYSIS are more accurate and efficient in picking up high-grade disease.
Dr Cholkeri-Singh (Naperville, IL), a long time user of DYSIS and lead author of the paper commented that “Utilizing the DYSISmap, has enabled gynecologists to increase detection and improve biopsy accuracy in the detection of dysplastic/cancerous lesions of the cervix. The publication of this paper is a step towards standardizing colposcopy, improving clinical education and patient outcomes.”
Alastair Atkinson, CEO of DYSIS Medical (Edinburgh, UK), manufacturer of the DYSIS digital colposcope stated that “The IMPROVE trial is highly significant demonstration of the effectiveness of the DYSIS Colposcope in community based clinics in the USA. The breadth and depth of the trial is substantial and shows how DYSIS is making a vital contribution to women’s healthcare”
For more information, watch the DYSIS Ultra 3-minute movie.
The DYSIS Colposcope uses a proprietary technology to create an adjunctive map of the cervix that highlights areas of interest to a clinician and assists in the selection of appropriate biopsy points.
DYSIS Medical Ltd
DYSIS Medical Ltd has its Headquarters in Edinburgh, UK and US offices 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.
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