VIO Imaging for Skin Tissue Assessment (VISTA) (VISTA)

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

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 Overview

• Status: Completed
• Conditions: Skin Diseases; Skin Abnormalities; Skin Cancer; Skin Lesion; Skin Condition
• Intervention / Treatment: Device: VIO Imaging

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Merced, California, United States, 95340
      • Golden State Dermatology
    • Walnut Creek, California, United States, 94598
      • Golden State Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is between 18 and 99 years of age.
2. The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent.
3. The subject is planning to undergo a routine skin biopsy.
4. The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture.
5. The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.

Exclusion Criteria:

1. The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
2. The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.

3. The subject's lesion targeted for biopsy:

   1. Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
   2. Has dense hair that will not be removed prior to the skin biopsy.
   3. Has clinically significant abraded or ulcerated skin with or without discharge.
   4. Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
   5. Is located in mucosal tissue (i.e., oral, nasal, etc.).
   6. Is on tattooed skin.
   7. Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)

   8. Is located in the periorbital region or directly on the eyelid.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIO Imaging; Subjects with skin conditions that are candidates for biopsy	Device: VIO Imaging; Skin conditions that are candidates for skin biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative Reader Percentage Agreement	This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). "CRs" were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase.	8 months post-enrollment completion
Blinded Reader Percentage Agreement	This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. "BRs" were study investigators that were selected based on their experience and medical qualifications. >90% agreement was required to proceed to the next study phase.	8 months post-enrollment completion
Safety / Adverse Events	Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.	7 +/- 3 days after VIO imaging

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-Reader Percentage Agreement	This outcome measured the inter-reader % agreement between N=3 Blinded Readers (BRs) during image analysis. Minimum 90% agreement was required to proceed to the next study phase.	8 months post-enrollment completion
Evaluation of Secondary Histopathology Characteristics	This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of secondary histopathology characteristics in VIO images in comparison to the answer key developed from the Comparative Reader validation. >90% agreement was required to proceed to the next study phase.	8 months post-enrollment completion

Collaborators and Investigators

• Sponsor: Enspectra Health
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Michael Wang, MD, FAAD, Golden State Dermatology

Publications and helpful links

General Publications

• Ward WH, Farma JM, editors. Cutaneous Melanoma: Etiology and Therapy [Internet]. Brisbane (AU): Codon Publications; 2017 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK481860/

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Skin Diseases; Skin Abnormalities
• Other Study ID Numbers: CR-30096; 2R44CA221591-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No