VIO Imaging for Skin Tissue Assessment (VISTA)

Not Applicable

Completed

Conditions: Skin Cancer
Skin Diseases
Skin Abnormalities
Skin Lesion
Skin Condition

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.

Recruitment & Eligibility

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:
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.

Arm && Interventions

Group	Intervention	Description
VIO Imaging	VIO Imaging	Subjects with skin conditions that are candidates for biopsy

Primary Outcome Measures

Name	Time	Method
Comparative Reader Percentage Agreement	8 months post-enrollment completion	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.
Blinded Reader Percentage Agreement	8 months post-enrollment completion	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.
Safety / Adverse Events	7 +/- 3 days after VIO imaging	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.

Secondary Outcome Measures

Name	Time	Method
Inter-Reader Percentage Agreement	8 months post-enrollment completion	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.
Evaluation of Secondary Histopathology Characteristics	8 months post-enrollment completion	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.