At a glance
ClinicalIndex Comparison Record- ✓Age 18-99 years
- ✓Planning to undergo a routine skin biopsy
- ✓Able and willing to remain still for up to 3 minutes for image capture
- ✓Able to provide informed consent or has a legally authorized representative who can
- ✕General health condition or systemic disease that precludes participation per physician judgment
- ✕Known allergy or increased skin sensitivity to silicone, adhesives, or glycerin
- ✕Lesion on palms, soles, fingernails, or toenails
- ✕Lesion with dense hair that will not be removed prior to biopsy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
In Brief
A clinical study evaluating VIO Imaging for Skin Condition and 4 related conditions. Completed, enrolled 65 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Skin conditions that are candidates for skin biopsies