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.


Louwers et al, GynOnc, 2015

A clinical trial on colposcopy with DYSIS was conducted at the outpatient colposcopy clinics of three Dutch hospitals.

The performance of Dynamic Spectral Imaging colposcopy depends on indication for referrals.

For the full publication click here: http://www.sciencedirect.com/science/article/pii/S009082581530158X

 

Overview:

This is another publication presenting results from the DYSIS trial in the Netherlands, focusing on sensitivity across different patient groups and referral pathways.

 

Purpose:

To further analyse the diagnostic value of adding Dynamic Spectral Imaging to conventional colposcopy for specific sub-groups of women.

 

Design:

Women with an abnormal screening results had colposcopy with DYSIS. They were first assessed conventionally and then the DYSISmap was revealed; biopsies were taken from sites suspected by the colposcopist or indicated by the DYSISmap. An additional, random, biopsy was taken from every patient to reduce ascertainment bias. Histology was used as gold standard.

 

Findings:

After incorporating the DYSISmap to colposcopy, the sensitivity for high-grade (CIN2+) disease increased from 44% to 85% on patients with low-grade cytology, and from 64% to 91% on those with high-grade cytology. The sensitivity increased significantly when different referral strategies were analyzed and also when the threshold for analysis was increased to CIN3+. This shows that the performance is robust and that the additional disease that is detected is clinically relevant.

 

Conclusions:

Integrating DYSIS mapping into colposcopy leads to a significant improvement in the detection of high-grade cervical lesions, irrespective of patient referral.

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