Clinical Evidence

Clinical Research conducted on DYSIS

Details of the various clinical trials and peer reviewed publications are available below. The US Federal Regulations restricts the display of certain non-US clinical data. Please declare your home country by selecting the appropriate tab below.


Zaal et al, BJOG, 2012

Agreement between colposcopic impression and histological diagnosis among human papillomavirus type 16-positive women: a clinical trial using dynamic spectral imaging colposcopy

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Overview:

A retrospective analysis of the 2011 Dutch  study results by Zaal et al was published in 2012. This study developed an understanding of the DYSIS sensitivity by HPV-type for all detected lesions and demonstrated that DYSIS has a sensitivity of 97% to detect high-grade lesions among patients infected by HPV-16 (the most oncogenic virus type). Additionally, a conclusion was drawn that traditional colposcopy might lose sensitivity due to the difficulty of visualizing small high-grade lesions.

Purpose:

To compare the sensitivity of traditional colposcopic impression with that of DYSIS colposcopy for the detection of cervical lesions in HPV-16 and non-HPV-16 high risk women

Approach:

A three-centre, prospective clinical trial conducted in hospitals in the Netherlands. The DYSIS colposcope was used to compare traditional colposcopic impression with DYSIS colposcopy (using the DYSISmap and standard indicators) to identify biopsy sites. Biopsies were gathered from all indicated sites and sent for histological analysis. HPV typing was performed on all patients.

Results:

More CIN2+ lesions were identified among HPV-16 positive women by DYSIS colposcopy than by traditional colposcopy than in non-16 HPV positive women. Traditional colposcopy missed smaller cervical lesions.

Conclusions:

DYSIS colposcopy is more sensitive for HPV-16 positive than in non-16 HPV positive women. Additionally, DYSIS colposcopy is greater than traditional colposcopy irrespective of HPV status probably because smaller lesions are harder to visualise.

Testimonials

Women’s Care Florida adopted a DYSIS Colposcope to improve their standard of care. Dr Kapitz tells us how it has improved cervical…
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Donovan Miske tells us how the DYSIS Colposcope has increased the level of care across all 3 of the practice locations.
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Dr Fellenbaum tells us how the DYSIS Colposcope has helped to offer his patient's the best care possible.
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