In Vivo Cross-Modal Imaging of Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-02

Study Completion Date

2025-09-30

Brief Summary

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The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

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Detailed Description

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The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

Conditions

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Skin

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Skin conditions

Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)

Intervention Type DEVICE

Skin Condition

Participants with Skin conditions or participants without any skin conditions (Healthy)

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

2 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes