VISTA Trial Validates Noninvasive Tool for Skin Feature Identification

A novel imaging system may offer dermatologists a noninvasive alternative to assess histologic skin features, according to results from the VISTA Trial published in JAMA Dermatology.

The multisite trial evaluated Enspectra Health’s VIO handheld cross-modal imaging system, which integrates reflectance confocal microscopy and multiphoton microscopy to generate histology-like images of skin. The study enrolled 65 patients undergoing routine biopsy, with imaging performed prior to tissue collection. Dermatopathology-trained physicians then analyzed these images using a standardized protocol.

In the study, physicians identified primary histologic features with 96.4% accuracy and secondary features with 98.5% accuracy, supported by high inter-reader agreement. Validation against traditional pathology confirmed these findings.

"This study shows that physicians can reliably identify histologic features such as collagen, pigment, hyperkeratosis, atypia, and solar elastosis using VIO's cross-modal imaging," said Dr. Sarah Arron, lead author of the study. "These features are key to understanding skin health, and noninvasive visualization opens new possibilities for both medical and aesthetic applications."

Participants in the trial represented Fitzpatrick skin types I through V, with 13.8% identifying as Hispanic, supporting the system’s applicability across diverse skin tones. Lesions were imaged across a variety of anatomic sites, further demonstrating clinical versatility.

The system has received FDA 510(k) clearance (K232789) for acquiring and displaying in vivo images of key skin structures. However, it is not intended to replace biopsy or to diagnose disease; it is cleared to assist qualified physicians in clinical decision-making.

While the VISTA Trial focused on lesional skin, investigators noted that noninvasive imaging may also benefit aesthetic dermatology, including treatment planning and monitoring.

"These features are key to understanding skin health, and noninvasive visualization opens new possibilities for both medical and aesthetic applications," the authors wrote. "Cross-modal imaging may support pre-treatment assessment, post-treatment monitoring, and personalized aesthetic planning."