LED Medical Diagnostics, a developer of tissue fluorescence visualization technologies, has announced that its patented VELscope Vx oral examination device is presently involved in a Phase III study, which is sponsored by the University of British Columbia in collaboration with the Terry Fox Research Institute and the British Columbia Cancer Agency.
The study, titled 'Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer', intends to find out if fluorescence visualization (FV) guided surgery will increase recurrence-free survival in oral cancer patients.
The University of British Columbia, along with the Terry Fox Research Institute, has shown that direct fluorescence visualization tools can effectively identify clinically visible or occult premalignant and malignant lesions that are linked with lesions at risk with high-grade histology and high-risk molecular change.
The study is utilizing LED Medical's VELscope Vx Enhanced Oral Assessment System, which centers on a hand-held scope that allows for direct visualization of tissue fluorescence in the oral cavity.
A longitudinal study has commenced to explore the effect of FV to define the surgical margin on the outcome of oral surgery.
LED Medical Diagnostics CEO Peter Whitehead noted that this particular study is unique in that it explores in a multi-centre design not only the efficacy of using the VELscope Vx for lesion excision but also the resultant effect on long-term recurrence rates.
"VELscope technology is the first tissue fluorescence technology to receive FDA and Health Canada clearance to assist surgeons in determining the appropriate surgical margin for the successful excision of oral cancer and pre-cancer. We are confident the study will further support its importance for this application," Whitehead added.
