NCT05619471

VIO Imaging for Skin Tissue Assessment (VISTA)

VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Enspectra Health · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment. To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy. To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.

Conditions

• Skin Condition
• Skin Diseases
• Skin Lesion
• Skin Abnormalities
• Skin Cancer

Interventions

Type	Name	Description
DEVICE	VIO Imaging	Skin conditions that are candidates for skin biopsies

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2022-11-17
• Last updated: 2024-07-25
• Results posted: 2024-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study