Cross-modal in vivo imaging of skin microstructure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses the VIO/FG-30350 device to capture microscopic images of skin at multiple anatomic locations in participants with a range of skin health. Investigators will compare those microscopic features with macroscopic (visible) skin characteristics to identify correlations. Participants aged 2–90 who can consent (or whose guardians can consent) and provide feedback will undergo noninvasive imaging during study visits. Anonymized data will be shared with the sponsor and regulatory bodies for analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants, ages 2 - 90 years old

Participant, 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.

Participant 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.

Participant and guardian, if applicable, must comply with the protocol requirements.

Participant 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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Where it's running

• Enspectra Health
  Mountain View, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.