Clinical Trials
The internal trials have provided Zilico with enough confidence in the referral device to launch a multi-centre trial in UK and Ireland. Building on the experience of using these devices in the clinic, Zilico has made changes to the operation of the device that should lead to performance improvements.
Referral Device
In April 2009, Zilico started a multi-site clinical investigation to establish the clinical utility of using the device in colposcopy clinics. This study will include 4 separate sites in the UK and Europe and be conducted in 2 phases.
Screening Device
The cervical screening market has different requirements in terms of performance and usability compared with the colposcopy clinic – e.g. higher specificity and less skilled users. Zilico will establish a detailed performance specification and clinical trial protocol for the device in consultation with opinion leaders in the UK and Europe.