N/A
Completed N=65
VIO Imaging for Skin Tissue Assessment (VISTA)
Skin Condition · Skin Diseases · Skin Lesion · Skin Abnormalities
Source: ClinicalTrials.gov NCT05619471 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Comparative Reader Percentage Agreement — 100; 100 percentage of agreement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparative Reader Percentage Agreement |
100; 100 | — |
| PRIMARY Blinded Reader Percentage Agreement |
94 | — |
| PRIMARY Safety / Adverse Events |
— | — |
| SECONDARY Inter-Reader Percentage Agreement |
94; 93 | — |
| SECONDARY Evaluation of Secondary Histopathology Characteristics |
98 | — |
Eligibility Criteria
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.
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Data sourced from ClinicalTrials.gov (NCT05619471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.