VIO Imaging for Skin Tissue Assessment (VISTA)

Study Overview
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Brief Summary
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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.

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

Conditions
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Skin Lesion, Skin Abnormalities, Skin Condition, Skin Diseases

Intervention / Treatment
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* Device: VIO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Skin conditions that are candidates for biopsy<br> | Device: VIO<br>* Skin conditions that are candidates for skin biopsies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Effectiveness | 1. 100% agreement and validation of specific tissue features on VIO images (epidermis, dermis, collagen, blood vessels and pigment) in comparison to gold standard pathology images in Comparative Reader assessment. | 3-months post-Enrollment completion | 
| Safety and Effectiveness | 2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment. | 3-months post-Enrollment completion | 
| Safety and Effectiveness | 3. 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. | 7day +/- 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) 90% inter-reader agreement during image analysis phase of the study on the images captured using the investigational device | 1) 90% inter-reader agreement during image analysis | 3 months post enrollment completion | 
| 2) Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captures on investigational device VIO | Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captured on the investigational device VIO; including but not limited to Dermal elastosis Cellular nodules within dermis will be evaluated during image analysis Large keratinocytes | 3 months post enrollment completion |