Referral
This device is aimed at the colposcopy market. It will optimise the role of colposcopy to one of pin-pointing the location of the pre-cancerous lesion or cancer. It will enable clinicians to reduce the number of diagnostic biopsies required and therefore avoid over-treatment of mild abnormalities. Real time results will also reduce the anxiety suffered by women.
Key Benefits
- Better differentiation between high-grade and low-grade abnormalities
- Reduction in the number of diagnostic biopsies required
- “Real-time” results for patients
- Better predictive values when compared to colposcopic impressions
- Potential to move to a “See and Treat” model of patient care based on removing the need for diagnostic biopsies entirely.
Clinical Trials
A multi-site clinical investigation trial was completed in 2011. This trial established the utilitiy of using the referral device in colposcopy clinics. The study was across three sites, two in the UK and one in Europe and recruited 400 women. The data from the trial which has already been dissiminated at key meetings demonstrates that the use of the device is better at identifying cervical neoplasia when compared to colposcopic impression.