N/A
Completed N=122
Non-Linear Imaging of Skin In Vivo
Skin Cancer · Skin Condition · Skin Diseases · Skin Lesion
Source: ClinicalTrials.gov NCT05410964 ↗
Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: VIO System Imaging Performance — 122 # participants with acceptable images
Summary
The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VIO System Imaging Performance |
122 | — |
| PRIMARY VIO System Image Quality |
122 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects, ages 2 - 90 years old.
- Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.
- Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.
- Subject and guardian, if applicable, must comply with the protocol requirements.
- Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies.
Exclusion Criteria
- Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use
- Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)
- Any known allergies to any materials used in the preparation of skin and/or device use
- Has a temporary or permanent electrical implanted medical device
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Data sourced from ClinicalTrials.gov (NCT05410964). 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.