VIO Imaging for Skin Tissue Assessment (VISTA)

NCT05619471 | Completed Results FDA Device

• 2 other identifiers: CR-300962R44CA221591-03
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Inter-Reader Percentage Agreement

  8 months post-enrollment completion

• Evaluation of Secondary Histopathology Characteristics

  8 months post-enrollment completion

Study Arms (1)

VIO Imaging

EXPERIMENTAL

Subjects with skin conditions that are candidates for biopsy

Device: VIO Imaging

Interventions

VIO Imaging DEVICE

Skin conditions that are candidates for skin biopsies

VIO Imaging

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
• The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.
• The subject's lesion targeted for biopsy:
• Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
• Has dense hair that will not be removed prior to the skin biopsy.
• Has clinically significant abraded or ulcerated skin with or without discharge.
• Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
• Is located in mucosal tissue (i.e., oral, nasal, etc.).
• Is on tattooed skin.
• Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)
• Is located in the periorbital region or directly on the eyelid.

Sponsors & Collaborators

• Enspectra Health: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Golden State Dermatology

Merced, California, 95340, United States

Location

Golden State Dermatology

Walnut Creek, California, 94598, United States

Location

Related Publications (1)

• 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/

  PMID: 29461771 BACKGROUND

MeSH Terms

Conditions

Skin Diseases; Skin Abnormalities; Skin Neoplasms

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: President
• Organization: Enspectra Health

clinical@enspectrahealth.com

650 480-6022

Study Officials

• Michael Wang, MD, FAAD

  Golden State Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 17, 2022
• Study Start: October 20, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Locations

US (2)