RecruitingNCT07188948
In Vivo Cross-Modal Imaging of Skin
In Vivo Cross-Modal Imaging of Skin - VISION2
Sponsor
Gabriel Sanchez
Enrollment
15 participants
Start Date
Sep 2, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 2 YearsMax Age: 90 Years
Inclusion Criteria5
- 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 Criteria5
- 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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Interventions
DEVICESkin conditions
Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)
DEVICESkin Condition
Participants with Skin conditions or participants without any skin conditions (Healthy)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07188948