Clinical trial NCT05619471: VIO Imaging for Skin Tissue Assessment (VISTA)
Official title: VIO Imaging for Skin Tissue Assessment (VISTA) - a Prospective, Multicenter Investigation of the VIO Device in Subjects Undergoing Routine Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Skin Diseases
Skin Lesion
Skin Abnormalities
Skin Cancer
Lead sponsor: Enspectra Health
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2022-11-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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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Primary outcomes:
measure: Comparative Reader Percentage Agreement
timeFrame: 8 months post-enrollment completion
measure: Blinded Reader Percentage Agreement
timeFrame: 8 months post-enrollment completion
measure: Safety / Adverse Events
timeFrame: 7 +/- 3 days after VIO imaging
Secondary outcomes:
measure: Inter-Reader Percentage Agreement
timeFrame: 8 months post-enrollment completion
measure: Evaluation of Secondary Histopathology Characteristics
timeFrame: 8 months post-enrollment completion
Other outcomes:
Locations:
city: Merced
country: United States
facility: Golden State Dermatology
state: California
city: Walnut Creek
country: United States
facility: Golden State Dermatology
state: California
Study officials:
affiliation: Golden State Dermatology
name: Michael Wang, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/