VIO Imaging for Skin Tissue Assessment
Enspectra Health announced that the first subject has been enrolled in its VISTA US Pivotal Study. VIO Imaging for Skin Tissue Assessment (VISTA) is a prospective, multi-center study designed to demonstrate the safety and effectiveness of the VIO System in subjects planning to undergo routine skin biopsy.
VISTA US Pivotal Study
The study will include up to 65 subjects, obtaining non-invasive in vivo images that depict tissue features including epidermis, dermis, collagen, blood vessels and pigments using the VIO System.
Related: AviClear 12-Month Clinical Data Presented at 42nd Clinical Dermatology Conference
Following a biopsy, images obtained with the VIO System will be compared to the images procured by the skin biopsy. The study will also discuss clinicians' ability to correctly identify tissue features on images obtained with the VIO System.
Groundbreaking New Tool
"The VIO System has the potential to become a groundbreaking tool for pathological evaluation of the skin, by allowing visualization of skin cells and structures in real time," said Michael Wang, M.D., Dermatologist and Dermatopathologist with Golden State Dermatology.
Golden State Dermatology will serve as the valued clinical study partner for Enspectra Health for the VISTA Pivotal Study. Subjects will be enrolled at three Golden State Dermatology locations around the greater San Francisco Bay Area.
