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VIO Imaging for Skin Tissue Assessment (VISTA)

NCT05619471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-07-25

Study results available
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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

DEVICE

VIO Imaging

Skin conditions that are candidates for skin biopsies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Enspectra Health

    lead INDUSTRY

Principal Investigators

  • Michael Wang, MD, FAAD · Golden State Dermatology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-08-11
Completion
2023-08-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619471 on ClinicalTrials.gov